Careers at ViaCyte

Company Overview

ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

Key Responsibilities

• Provide regulatory support (defined in Section III.2.c) to product development objectives through organized and timely regulatory submissions.
• Ensure that the timing and content of regulatory submissions meet regulatory agency expectations and achieve regulatory clearance without delaying manufacturing timelines, clinical trial timelines and other development activities.
• By organizing effective document review processes ensure completeness, accuracy and appropriate messaging of regulatory submissions.
• Proactively assist development teams and management in awareness and understanding of new and evolving regulatory requirements and their impacts.
• Contribute to continuous improvement through the QMS.
• Ability to project a positive constructive attitude in communications to inspire cooperation and teamwork among peers and management members.

Qualifications

Education & Work Experience Requirements

• Minimum of a bachelor’s degree in biological sciences or related field is required.
• Regional scope: 7 years’ experience in providing regulatory support to sponsors (manufacturers, specification developers and/or dossier applicants) in U.S.; experience with Canada, UK, or EMA or EU member states is a plus.
• Product life-cycle scope: Experience with investigational medical products development; experience with commercial stage medical products is desired.
• Regulatory support scope: Experience providing such work products as: clinical trial applications (INDs), amendments and associated meeting packages and written communications for biological drug products; medical device pre-market clearance applications (510(k)s, PMAs) in combination with parenteral biologic or drug products, and associated pre-submission packages; or biologic or drug product market authorization applications (NDA’s, BLA’s, MAA’s or PMA’s); maintaining logs and archives of searchable and retrievable regulatory agency written and verbal communications.

Experience/Knowledge/Abilities

• Knowledge of regulatory requirements for cellular therapies.
• Experience with sterile products or parenteral products requiring aseptic processing.
• Computer skills and written communication skills in order to complete the reports and paperwork required by regulatory bodies.
• Expert level familiarity with applicable biological drug and medical device regulations and guidelines issued by standards agencies (e.g., ICH, ISO, PDA) and regulatory agencies.
• Effective communication skills to keep other managers and department heads informed of regulations and policies with which they must comply.
• Must be highly organized and possess meticulous attention to detail.
• Strong communication skills, both written and verbal, are required.
• Must be skilled in Microsoft Office, including Word and Excel.
• Ability to project a positive constructive attitude in communications to inspire cooperation and teamwork among peers and management members.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-33 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

The Clinical Trial Assistant will assist and work in collaboration with a Sr. Clinical Trial Manager (or another member of the departmental leadership team), to ensure timely completion of program activities.  The essential duties and responsibilities will include, but are not limited to:

• Manage various aspects of day-to-day operations of clinical trials as assigned.
• Provide general support to the Sr. Clinical Trial Manager (CTM) or CTM and field Clinical Research Associates (CRAs) to manage the investigator sites and ensure compliance.
• Manage the collection, review and tracking of essential regulatory documents in support of new clinical study site activation.
• Manage and serve as a point of contact for contract research organization (CRO) and third-party vendors; identifying potential risks and proactively resolving issues that arise.
• Ensure all clinical sites are provisioned with appropriate ancillary supplies, investigational product, and associated documentation by establishing purchase orders, processing orders, and arranging for delivery by vendors and/or internal departments as necessary.
• Collect and process clinical site surgical notification forms; add surgical procedures to calendar from study-specific distribution list.
• Manage all investigational product (IP) requests, including, but not limited to: IP manufacturing requests, tracking of all IP shipping and delivery, IP accountability logs, and inventory reports.
• Create explant plans for review by CTM; send plan to clinical site and update internal calendar as needed.
• Upload study procedure surgical photos and videos to local drives.
• Establish templates within electronic Trial Master File (eTMF) system.
• Collect and process electronic case report form (eCRF) access requests from clinical sites and internal team members.
• Assist in the development of reports for communicating study progress and key metrics to the management team.
• As needed, travel to investigator sites to assist with site monitoring, reviewing source documents, CRF entries, regulatory files, IP accountability records, and all other relevant study documents to ensure site compliance and data validity.
• Schedule & set up necessary tele- or videoconferencing meeting requirements for Clinical Development team as needed.
• Capture and file minutes for in-house meetings and conference calls with CROs, vendors, and cross-functional teams.
• Review and update Standard Operating Procedures (SOPs).
• Maintain effective communication with study teams throughout study cycle.
• Complete other study-related tasks as required by Clinical Development Team members.

Our dynamic workplace is attractive to those who are self-motivated and resourceful.  You will be expected to set priorities within your job scope and to meet critical deadlines.  Flexibility to handle rapidly changing objectives and timelines is essential.

Requirements

A college degree in a biological or engineering science is required.  A minimum of one year of work-related clinical research industry experience is preferred.  An equivalent combination of education and experience to successfully perform the job duties listed above is acceptable.  Excellent teamwork, decision-making and organizational skills are required. Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements is necessary.  Familiarity with diabetes, metabolic disease, cell therapy, and/or cutting edge translational medicine is strongly desired.  Strong verbal and written communication skills are required including ability to organize and present concepts with written, oral, and technical media / approaches.  Candidates must be skilled in Windows, Microsoft Project, and Microsoft Office.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-10 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

Desktop Support Technician that will be responsible to work with end users who are having problems with hardware, software or networking issues; work under the direct supervision of the head of IT department. This is a full-time position.

Responsibilities:

1. Provides timely and accurate end user’s desktop OS and application support primarily on the Microsoft platform. Answers incoming requests for assistance from users experiencing problems with hardware, software, networking, and other computer-related technologies.
2. Speaks with user to collect information about problems and leads user through diagnostic procedures.
3. Triages the problem to identify if the source of the problem is hardware or software such as application, printer, cables, telephone, network, etc.
4. Handles problem recognition, research, resolution and follow-up for routine user problems and escalating more complex problems to the head of the IT department.
5. Responsible for maintaining hardware and software inventory, IT asset tracking, support ticketing, and software compliance.
6. Perform hardware and software installation, configuration, and maintenance.
7. Upgrade and troubleshoot various workstation and laptop hardware.
8. Troubleshoot wired and wireless network issues including minor cable termination.
9. Troubleshoot printers.
10. Email and smartphone support.
11. Perform VPN client configuration and support.
12. Provide basic phone system end user support.
13. Support Audio/Visual and conference rooms, support hardware and network systems, phone, projector and video conference equipment.
14. Flexibility to handle rapidly changing objectives and timelines is essential.

Experience:

• Excellent customer service skills to effectively provide oral and written communication to end users at all levels within the organization.
• Strong technical ability and troubleshooting skills.
• Strong experience in the support of Client desktop environment, especially Microsoft Windows 7/10 operating systems, Office 2016/2019 and Microsoft 365 suite of applications, Adobe Acrobat, Zoom and VPN technologies.
• Installing and maintaining LAN/Desktop Hardware and Software systems including Windows 7/10, Office 2016/2019 and Microsoft 365 suite of applications and multiple hardware platforms.
• Ability to setup and configure desktop and laptop computers, printers and other accessories to company standards, and perform minor to medium level troubleshooting to computer hardware and peripherals.
• Detail-orientated, organized, strong time management skills with the capacity to meet deadlines and prioritize support incidents and respond promptly, competently, and patiently.
• Strong sense of responsibility, accountability, and integrity.
• Able to regularly lift up to 50 pounds.

Education:

• An associate degree in MIS Computer Science or related field as a minimum.
• 2-4 years minimum help desk or technical support experience, A+ or Microsoft desktop certification is a plus.

An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code: 2021-05 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy 

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

ViaCyte is seeking a highly motivated and talented individual to join the Process Development (PD) team in developing scalable production processes in bioreactors for a cell-based therapy to treat diabetes. This position is open to individuals that have experience supporting process development at a senior associate level and/or working with a PD team at a process Engineer II level. The primary activities of the Sr. PD Associate / Engineer II will be to design new approaches to perform human embryonic stem cell (hESC) expansion and differentiation experiments, and support process characterization, optimization and scale-up. Secondary activities include lab management, data entry, and support of other PD projects. This position is open to This is a full-time position located in San Diego, CA.

Duties and Responsibilities

1. Plan cell culture activities required to grow and differentiate hESCs.
2. Execute cell culture and analytical experiments under written protocols. Cell culture will be performed using multiple platforms (e.g. multi-layer cell factories, roller bottles, bioreactors, etc.). Assay methods include, but are not limited to, polymerase chain reaction (PCR), expression profiling, ELISA, and metabolite analysis.
3. Manage analytical workflow for hESC scale-up sub-team, including ordering, restocking, and data management.
4. Evaluate and integrate new technologies into hESC production process.
5. Document experimental procedures and results according to established guidelines. Present updates and results at internal PD team meetings.
6. Interact with external departments (e.g. Quality, Manufacturing)
7. Perform cleaning and maintenance activities required to ensure a contamination-free environment.
8. Support general laboratory and equipment maintenance as required.

Requirements

BS/MS degree that included laboratory work in a Biology, Biomedical Engineering, or related field. Two to five years of laboratory experience in an academic, biotechnology, or pharmaceutical setting is preferred, or equivalent work experience sufficient for successful performance of the job duties as listed above is acceptable.

• Experience with mammalian cell culture and/or in a cGMP manufacturing/laboratory environment preferred.
• Proficiency in cell culture aseptic techniques is required.
• Must have a flexible schedule and be able to work some weekends and holidays.
• Ability to work independently and as a team member.
• Ability to follow detailed instructions and to maintain detailed and accurate records and notes.
• Ability to successfully perform multiple tasks and changing priorities, when required.
• Skill in problem solving and troubleshooting.
• Ability to safely operate production equipment in accordance with established practices.
• Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel, imaging and illustrating software, and specialized applications in use in the laboratory.
• Strong verbal and written communication skills are required.
• Willingness to learn and contribute, with a team-oriented attitude.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

The ideal candidate will have experience in both process development and engineering and will be technically strong and adept at managing multiple priorities. Our business moves at a rapid pace, making resourcefulness and flexibility key contributors to success.

This position is not eligible for relocation.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, type Job Code 2021-02 and your full name. Send to hr@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

This position will focus on quality control activities supporting the manufacture of therapeutic cell products, implantable devices, and cell therapy combination products.

Requirements

QC associate will work in both laboratory and cleanroom environments under SOP’s for performing environmental monitoring.  Responsibilities include: sampling using EM equipment, sample handling, reporting results with accurate documentation, maintaining database of results, investigation of OOS’s, and determination of root cause as appropriate.

Other responsibilities include quality review and release of all incoming GMP materials; Inventory control management and preventative maintenance activities. Raw material, In-process and lot release sample handling, testing and tracking.  Assisting with other duties as needed.

• Ensure adherence to all company policies, quality policies, and SOPs.
• Perform Environmental monitoring.
• EM sample handling.
• Report results and database management.
• Receiving activities for GMP supplies/materials-including proper documentation review, and disposition.
• Quarantine and storage of materials as required.
• In- process and release test sample handling, testing and tracking.
• Raw material sample handling, testing and tracking.
• Inventory control of retains/ raw materials and other QC materials.
• Purchase general supplies and EM supplies as needed.
• Responsible for preventative maintenance general upkeep of the QC EM equipment and areas.
• Perform other duties as assigned.

Education

• This position requires a bachelor’s degree, life sciences preferred, and a minimum of 1 year of biotechnology or industry related clinical trial and/or supply management experience.
• An equivalent combination of education and experience is sufficient to successfully perform the job duties is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code: 2021-25 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

ViaCyte is seeking an experienced Supply Chain Sr. Manager or Director to perform a broad range of tasks supporting cGMP and R&D activities related to the robust, reliable, and cost-effective purchase distribution of materials.  This position includes hands-on and managerial participation, including vendor engagement, materials logistics, inventory control, shipping, & receiving.  This is a full-time position.

Essential Duties & Responsibilities

1. Plan and implement activities related to the timely, cost-effective procurement, inventory control, planning, and quality of GMP and R&D materials.
2. Develop, implement, and maintain systemic policies, procedures, and material control systems to reduce costs, streamline processes, and implement solutions.
3. Ensure the availability of GMP materials in the supply chain, as scheduled, and the maintenance of inventory at minimum acceptable levels.
4. Responsible for vendor management, including sourcing and supplying raw materials, utilities, and outside services, and coordinating global procurement efforts.
5. Coordinate with finance/accounting on matters involving inventory-carrying costs.
6. Plan and review requirements for acceptable GMP inventory.
7. May assist with the establishment and maintenance of the GMP production control system.
8. May work with customers in auditing customer inventory levels and with internal and external vendors to comply with inventory policies.
9. Select, develop, and evaluate personnel to ensure the efficient operation of the function.

Experience Required

• Engagement with vendors to provide the best pricing, discounts, contracts, and supply agreements.
• The development and use of supply chain programs.
• Ability to effectively coordinate department activities with different functional groups within the manufacturing, R&D, quality, and operations departments.
• Experience in the development, management, and continuous improvement of policies and procedures related to supply chain, materials management, and logistics.
• Must be knowledgeable in all aspects of compliance in an environment regulated by the FDA, EMEA, and other applicable regulatory agencies.
• Must be skilled in Microsoft Office, including Word, Excel, and PowerPoint.
• Good verbal and written communication skills are preferred. Must be able to write and speak effectively across multiple departments/disciplines.

Education

A college degree or certification in supply chain, materials management, or logistics is preferred.

A minimum of 10 years of experience in supply chain, materials management, or logistics is required.  Experience in a Biotech, Pharma, or Health Care environment is preferred.

An equivalent combination of education and experience with biotechnology-related supply chain programs sufficient to successfully perform the job duties as listed above is acceptable

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code: 2021-04 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations and cover all human resource actions, including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview:

Join ViaCyte, Inc., one of the most innovative companies in diabetes research. ViaCyte, a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated.

ViaCyte’s innovative product candidates are based on two technology platforms:

1) stem cell expansion and differentiation, and

2) implantable devices for cell delivery (including the Encaptra® system)

We believe that ViaCyte has all of the elements it needs to successfully deliver transformative cell therapies for insulin-requiring diabetes, including cell and device platform technologies, know-how, expertise, intellectual property, and regulatory, clinical, and manufacturing experience.

For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

• Large scale culture and differentiation of gene edited human pluripotent stem cells (PSCs, including ESCs and iPSCs) using aseptic technique to manufacture cellular product.
• Analyze the progression of cell differentiation in vitro using real time gene expression using Nanostring platform.
• Assist in ensuring that there are sufficient materials available for manufacturing runs or campaigns, including media, small molecules, and growth factors.
• Prepare media and other reagents as required for manufacturing and other research activities.
• Assist team with editing efforts for target-related studies using CRISPR based gene editing.
• Understand applicable documentation, including batch records, SOP’s, deviations, change requests, IOQ’s, and other documents. Throughout the course of all job activities, maintain accurate records and documentation.
• Ability to effectively coordinate department activities with different functional groups within the company.
• Highly self-motivated and flexibility in working schedule to accommodate weekend work when necessary.
• Flexibility to handle rapidly changing objectives and timelines is essential
• Present data and findings to peers and managers.
• Prioritize work across multiple projects.

Qualifications:

Education:

A bachelor’s or master’s degree in cell biology or a related field, and a minimum of five years of laboratory experience is required.

Experience/Knowledge/Abilities:

• Extensive Pluripotent stem cell culture experience is required.
• Knowledge of clean room procedures and experience working in a clean room is highly desirable.
• Experience in genome engineering using CRISPR is preferred.
• Experience with molecular biology techniques especially RNA extraction, Nanostring, viability, cell death assays and ELISA is required.
• Knowledge of stem cell biology and/or developmental biology is preferred.
• Must be skilled in the Windows operating system and Microsoft Office, primarily Word, Excel and PowerPoint.
• Detail-orientated, organized, strong time management skills with the capacity to meet deadlines.
• Excellent oral and written technical communication skills.
• Strong sense of responsibility, accountability, and integrity.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code: 2021-13 and your full name.  Send to hr@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte has two product candidates in clinical-stage development, the PEC- Direct™ product candidate (also known as VC-02) and the PEC-Encap™ (also known as VC-01) product. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

This role will be responsible for performing analytical, biochemical, and/or biological testing, data review and trending, and/or related activities, in a reproducible and timely fashion, to support the process development of a cell-based therapy. The person in this position will also participate in the development and optimization of methods for process and product characterization. This is a full-time position.

Experience

• Demonstrated capabilities in the analysis of gene expression and other molecular biology techniques is required.
• Experience with aseptic technique, and strong bench skills are required.
• Knowledge of stem cell biology and/or developmental biology is desired.
• Must have demonstrated the ability and willingness to perform a wide variety of tasks – from those which are routine in nature to those which require independent thought and analysis.
• Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel.
• Strong verbal and written communication skills are required.
• Applicants should be self-motivated, organized, capable of working independently and in a collaborative environment.

Responsibilities

• Grow and passage cells in culture using aseptic technique, and maintain required documentation.
• Perform analytical testing (gene expression, bioassays, analyte concentration) of samples and maintain required documentation according to lab policy.
• Work under more senior supervision to advance the development of state-of-the-art techniques to support process and product characterization.
• Prepare media and other reagents per established procedures as required for the above activities.
• Analyze and trend gene expression in response to the progression of cell differentiation in vitro.
• Review data, assemble data tables and graphs, provide clear reports.
• Coordinate sample submission and testing schedule for the timely turnaround of results to support team projects.
• Perform equipment maintenance/qualification; maintain a safe and efficient workplace, following safe lab practices, participating in lab organization, housekeeping, and maintenance activities.
• Keep diligent records, and write reports and SOPs as needed.
• Regularly read and engage colleagues in discussions regarding relevant scientific literature, and present experimental results to the workgroup.

Requirements

A BS or MS degree in biology, biochemistry or a related field, and a minimum of two years of laboratory experience is required.
An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code:2021-01 and your full name. Send to hr@viacyte.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical-stage development. The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

ViaCyte is seeking a highly motivated and talented individual to join the Process Development (PD) team in developing scalable production processes in bioreactors for a cell-based therapy to treat diabetes. The primary activities of the PD Associate/Engineer I will be to design and perform human embryonic stem cell (hESC) expansion and pancreatic cell differentiation experiments in small- and pilot-scale bioreactor systems to test feasibility and perform process optimization and characterization as well as develop closed processes for media exchange and cell harvest. Secondary activities include lab management, data entry, and support of other PD projects. This is a full-time position located in San Diego.

Essential Duties & Responsibilities

1. Plan cell culture activities required to grow and differentiate hESCs in closed, suspension bioreactor systems.
2. Develop and define key bioreactor control parameters that maintain cell properties and allow for process reproducibility and scalability.
3. Optimize and close bioreactor cell culture processing activities by integrating new technologies
4. Execute cell culture and analytical experiments under written protocols. Cell culture will be performed using multiple platforms (e.g. multi-layer cell factories, roller bottles, bioreactors, etc.). Assay methods include, but are not limited to, gene expression, whole genome profiling, flow cytometry, and metabolite analysis.
5. Document experimental procedures and results according to established guidelines. Present updates and results at internal PD team and company meetings.
6. Perform statistical data analysis in JMP and other software platforms
7. Collaborate with external departments (e.g. Quality, Manufacturing, Engineering)
8. Support general laboratory and equipment maintenance as required.

Experience Required

• Experience with mammalian cell culture (stem cells preferred), and/or in a cGMP manufacturing/laboratory environment required.
• Experience with suspension bioreactor systems is preferred.
• Must have a flexible schedule and be able to work some weekends and holidays.
• Ability to work independently and as a team member.
• Ability to follow detailed instructions and to maintain detailed and accurate records and notes.
• Ability to successfully perform multiple tasks and changing priorities, when required.
• Skill in problem solving and troubleshooting.
• Ability to safely operate production equipment in accordance with established practices.
• Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel, imaging and illustrating software, and specialized applications in use in the laboratory.
• Strong verbal and written communication skills are required.
• Willingness to learn and contribute, with a team-oriented attitude.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.
The ideal candidate will be technically strong and adept at managing multiple priorities. Our business moves at a rapid pace, making resourcefulness and flexibility key contributors to success. This position is not eligible for relocation.

Education

• BS/MS degree that included laboratory work in a Biology, Biomedical Engineering, or related field.
• One or more years of laboratory experience in an academic, biotechnology, or pharmaceutical setting is preferred, or equivalent work experience sufficient for successful performance of the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, type Job Code 2021-15 and your full name. Send to careers@viacyte.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.
ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

The QA Specialist will support ViaCyte’s clinical and manufacturing development activities by ensuring that ViaCyte’s quality systems/procedures are following the applicable regulations/standards (e.g., US FDA, EU, and Canada).  The QA Specialist will communicate and interact with cross-functional teams by providing support in the following activities: supplier management, employee training, internal/external audits, SOP development and review, design control, statistical analysis, and other quality activities that may be assigned by Quality Management.

Essential Duties & Responsibilities

1. Provides support in supplier management activities (e.g., continuous monitoring of supplier performance, supplier evaluation and re-evaluation, analyze supplier trends and coordinate improvement activities, maintenance of supplier files, monitoring of change notifications from suppliers, developing quality agreements, review of supplier surveys, etc.). Presents supplier status to Quality Management.

1. Responsible for SOP development/revision and evaluation of their appropriateness in the development phase.
2. Reviews batch records and ensures that the review observations/comments noted during review are documented and communicated to the appropriate personnel to prevent future document errors/discrepancies.
3. Conducts internal and external audits to maintain compliance with ViaCyte procedures and applicable regulations and ensure active follow-up on findings/recommendations including CAPAs observed during the audits.
4. Develops metrics on audit findings and provides report in preparation for Management Review Meeting.
5. Coordinates the training of all GMP employees and ensure that training is conducted in sufficient frequency and develops methods on how to evaluate QA-led training effectiveness of employees.
6. Coordinates and schedules Management Review Board (MRB), Change Control Board (CCB), and Quality System Incidents Review Board (e.g., deviations, NCMRs, OOS, etc.).
7. Develop a system for timely follow-up of quality incidents including internal audits and metrics reporting.
8. Develop a system for documenting and coordinating batch record review observations to ensure corrections and comments are addressed in a timely manner.

Experience Required

• Experience working in a team environment and with proven ability to provide guidance that will promote good communication and cooperation among different teams.
• Strong knowledge of FDA and international regulations and standards.
• Must be skilled in Microsoft Office, including Word and Excel, with PowerPoint experience and Visio are preferred.
• Strong verbal and written communication skills are required.

• Self-motivation and independent initiative while often working without the benefit of established procedures.

• Strong knowledge of statistical techniques with relevant experience in data analysis, and trending quality metrics for continuous improvement.

• Must possess mobility to work in laboratory and office settings and to use equipment commonly found in these environments.
• Compliance with GMP protocols is required in certified cleanrooms.

• Laboratory and office space requiring adherence to standard safety and laboratory practices, with possible exposure to chemicals, blood borne pathogens, and other risks typically associated with working in a biological sciences research facility.

Education

• A bachelor’s degree in a scientific or related discipline, or a certification in a quality discipline (e.g., CQE, CQA).
• A minimum of 7 plus years of relevant work experience in biologics, combination product, medical device or pharmaceutical product manufacturing is strongly preferred.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-18 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as
potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia
and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic
progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once
implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response
to blood glucose levels. ViaCyte has two product candidates in clinical-stage development. The PEC-Direct™
product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective
device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme
glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01)
product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being
developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is also developing immuneevasive
‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the
availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California.
The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more
information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

The analyst in this position will perform a broad range of activities to characterize and release stem cell derived
pancreatic cells for in vitro, preclinical, and clinical studies. Responsibilities include the analytical
characterization of differentiated cells using qualified assays for cell proliferation, differentiation, and gene
expression. This is a full-time position.

Essential Duties & Responsibilities

1. Perform testing of routine and non-routine samples, and document according to GMP.
2. Participate in assay control testing, lot to lot antibody release, and product stability testing.
3. Analyze data, report results, and advise internal customers regarding outcomes of testing.
4. Write SOPs and reports as needed.
5. Maintain equipment and instrumentation to comply with GMP guidelines. Monitor instrument
performance to assure optimal operation. Assist with calibration, documentation, ordering and tracking
of materials
6. Support internal audits.
7. Actively participate in the development and/or optimization of analytical methods.

Experience Required

1. Demonstrated experience with aseptic cell culture methods, including cryopreserving, thawing and
culturing cell lines is essential.
2. Experience with cell-based assays (gene expression, flow cytometry, ELISA) is essential.
3. Experience performing testing in a regulated laboratory environment (cGMP, cGLP, clinical lab scientist)
is essential.
4. Ability and willingness to perform a wide variety of tasks – from those which are routine in nature to those which require independent thought and analysis.
5. Must be highly detail oriented, maintain accurate records, perform data analysis and communicate results through written and oral summaries.
6. Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel.
7. Strong verbal and written communication skills are required.

Education

BS/MS in cell or molecular biology and a minimum of five years of laboratory experience is required.
An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code:2021-24 and your full name. Send to careers@viacyte.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical-stage development. The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

Have a direct impact on helping ViaCyte cure Type One Diabetes! Viacyte is looking for a team-oriented Manufacturing Associate to assist in the production of clinical material intended to assist patients with type one diabetes. The candidate will perform a broad range of tasks in the cGMP manufacture of cells and combination cell therapy/device products for use in clinical and developmental studies. This position includes hands-on participation including materials logistics, assisting in manufacturing operations, and may include non-routine development activities. This is a full-time position with opportunity for growth.

Essential Duties & Responsibilities

1. Assist in manufacturing operations to produce GMP grade product to meet corporate goals.
2. Assist in ensuring that there are sufficient materials available for all production runs or campaigns including media, small molecules, and growth factors.
3. Provide hands on support for scale out/up and development activities as needed based on a demand plan.
4. Understand, revise and review applicable GMP documentation including batch records, SOP’s, deviations, change requests, CAPA’s, IOQ’s, technical reports, and other documents.
5. Maintain current training status for all applicable activities.
6. Assist in maintaining GMP areas in a constant state of inspection readiness related to equipment and area preventive maintenance, calibration, and certification.
7. Throughout the course of all job activities, maintain accurate records and documentation required to support regulatory submissions and comply with regulatory requirements.
8. Must possess mobility to work in cleanroom, laboratory, and office settings and to use equipment commonly found in these environments.

Experience Required

1. Experience culturing human embryonic stem cells is preferred.
2. Current knowledge and understanding of GMP principles and requirements as applied to the biotechnology manufacturing industry is preferred.
3. Ability to effectively coordinate department activities with different functional groups within the manufacturing and operations departments.
4. The ability to perform some weekend work is required.
5. Must be skilled in Microsoft Office, including Word, Excel, and PowerPoint.
6. Good verbal and written communication skills are preferred. Must be able to write and speak effectively across multiple departments/disciplines.

Education

A college degree in a biological or engineering science is preferred.
Minimum of 1 year of experience in cell culture-based manufacturing or development operations is preferred.
An equivalent combination of education and experience with cell culture manufacturing processes sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code: 2021-38 and your full name. Send to Careers@viacyte.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

As a member of the Cell Manufacturing/Combination Product team, the Manufacturing Associate II will perform a broad range of tasks in the cGMP manufacture of cells and combination cell therapy/device products for use in clinical and developmental studies.  This position includes hands-on participation including materials logistics, manufacturing operations, and may include non-routine development activities.  This is a full time position.    Assist in manufacturing operations to produce GMP grade PEC-01 and Combination Product to meet corporate goals

Essential Duties & Responsibilities:

Our dynamic workplace is attractive to those who are self-motivated and resourceful.  You will be expected to set priorities within your job scope and to meet critical deadlines.  Flexibility to handle rapidly changing objectives and timelines is essential.

1. Support materials logistics and manufacturing operations to produce GMP grade product to meet corporate goals.
2. Ensure sufficient materials are available for all production runs or campaigns including media, small molecules, and growth factors.
3. Provide hands on support for scale out/up and development activities as needed based on a demand plan.
4. Generate and revise applicable GMP documentation including batch records, SOP’s, deviations, change requests, CAPA’s, IOQ’s, technical reports, and other documents.
5. Maintain current training status for all applicable activities.
6. Maintain GMP areas in a constant state of inspection readiness related to equipment and area preventive maintenance, calibration, and certification.
7. Throughout the course of all job activities, maintain accurate records and documentation required to support regulatory submissions and comply with regulatory requirements.

Experience Required

1. Experience culturing human embryonic stem cells is preferred.
2. Current knowledge and understanding of GMP principles and requirements as applied to the biotechnology manufacturing industry is preferred.
3. Ability to effectively coordinate department activities with different functional groups within the manufacturing and operations departments.
4. The ability to perform some weekend work is required.
5. Must be skilled in Microsoft Office, including Word, Excel, and PowerPoint.
6. Good verbal and written communication skills are preferred. Must be able to write and speak effectively across multiple departments/disciplines.

Education

A minimum of 1 years’ experience in a GMP manufacturing environment is preferred.

An equivalent combination of education and experience with cell culture manufacturing processes sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-39 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview 

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.   

ViaCyte has two product candidates in clinical-stage development: 

• The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  
  

• The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  
  

• ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  
  

ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.  

Position Description 

Supporting key projects for ViaCyte, the Project Manager will work with the Core Team Leader to coordinate cross-functional team members, develop project plans, implement project tools, provide communications and overall management to deliver the projects on time and in scope.  As part of the PMO, you will be accountable for working closely with the project teams to execute the plan, implement new tools and processes to align to the company objectives and achieve the metrics and projects deliverables as agreed with the Governance Team. 

This position is full-time and located in San Diego, CA.  

Essential Duties & Responsibilities 

• Coordinate and manage project team activities, including potential 3rd party partners, for the optimal execution of projects.  
• Working with the Core Team Leader, develop project scopes, plans and objectives to execute activities.   
• Become the key point of contact for communications and coordination within the project team.   
• Manage the inputs to the project management artifacts, such as project contracts, status updates, action and decisions log and review materials for Governance meetings.  
• Establish and maintain collaborative relationships with 3rd party partners.  

Experience Required 

• 2-3 years of experience leading project teams, preferably in a Clinical, Med Device or Pharma company. 
• Proven written and communication skills and experience with Project Management processes, tools and templates. 

• Solid organization skills, attention to detail and multi-tasking capabilities. 
• Experience managing multiple projects in a cross-functional team environment. 
• Strong working knowledge of Microsoft Office and MS Project.
  

Education 

• Bachelor’s Degree in Engineering, Scientific or appropriate business field.  
• PMP certification or equivalent (preferred)
  

Application Procedure 

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code: 2021-41 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. 

Policy 

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs. 

Company Overview 

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. 

ViaCyte has two product candidates in clinical-stage development:  

• The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  
  

• The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  
  

• ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  
  

ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.  

Position Description 

Lead the Program Management Office (PMO) for ViaCyte, including the management of strategic alliance partnerships as well as hands-on project management of critical projects and objectives.  The PMO Director will facilitate the Project Governance needs and be accountable for executing multiple new processes to align the project management activities at ViaCyte.  The role could also function as a Chief of Staff to the Executive Staff dependent upon experience and qualifications.   

This is a full-time position located in San Diego, CA. 

Essential Duties & Responsibilities 

• Provide PMO support and guidance to in-progress high level projects, which will also include alliance management activities with external partners.  Ensure compliance to project deliverables and schedules.  
• Collaborate with cross functional senior leaders to continue the execution of the PMO activities in support of the projects.  
• Roll out PMO processes, procedures and training while mentoring projects through the new processes (tools, templates, systems).   
• Facilitate the Project Governance process, including the senior-leadership monthly meeting to review projects, objectives and metrics.  

• Manage a team of Project Managers who support functional level projects, providing mentoring, guidance and performance management.  
• Act as Chief of Staff providing communications, action items and tracking of corporate objectives and metrics. 

Experience Required 

• Minimum of 10 years’ experience as Project Manager, actively executing PM principles on large scale, cross-functional projects.  

• Background experience should be in BioTech, Medical Device, Pharma or Clinical development companies.  
• Experience developing and implementing Project Management processes. 
• Proven teamwork and collaboration skills, with a demonstrated ability to interact successfully with all levels of management. 
• Experience with managing and developing a team of project managers, including performance management.  
• Experience with Alliance Management and the management of external partners on large scale projects.  

• Experience with Metrics development and management.  
• Broad experience with multiple functional areas including R&D, Technology, Operations, Quality, Regulatory Affairs and Clinical.  
• Ability to influence and negotiate with multiple stakeholders without direct authority.  

Education 

• Master’s Degree in Engineering or Scientific field.   

• Master’s Certification in Project Management or PMP Certification 

Application Procedure 

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code: 2021-40 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. 

Policy 

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs. 

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

This individual will report into the Chief Operating Officer/Chief Financial Officer. He/ she will support ViaCyte’s Business Development activities focusing on pre-clinical and clinical stage business development opportunities, acting as a search and evaluation lead. The Director, Business Development must possess substantial scientific knowledge and experience working in industry to understand the drug discovery and development process, and how scientific assessment within business development can advance our portfolio interests. The role requires extensive experience in the pharmaceutical industry, including a broad and deep understanding of development, regulatory and (ideally) commercial experience. This individual will participate in the process for identifying, prioritizing and sequencing of projects within pre-clinical / clinical stage business development. There is an expectation that the process is owned by this person and ensure initiatives are in alignment with corporate strategy objectives. Acts as a communication conduit for business project status, actions, decisions, risk and issues and schedules for assigned projects to the Executive Leadership Team (ELT).

• Independently lead search and evaluation activities and projects in the regenerative medicine fields, both related to the cells and delivery technologies, to proactively identify and solicit new strategic research partnerships with biotech and pharmaceutical companies, academic institutions, non-profit research or patient organizations
• Work closely with relevant internal R&D teams to deeply understand their scientific strategy and align outreach strategy with existing and new areas of ViaCyte R&D focus to align on opportunity assessment
• Participate in and lead in-depth reviews and due diligence on external opportunities and act as a point of contact between the cross functional teams and ELT to ensure a successful collaboration
• Lead the activities/input necessary to establish the business case (scientific/ technical evaluation, development plan, market research, market opportunity, competitive intelligence, strategic assessment, appropriate transaction financial structure etc.) and present it to senior leaders in the business
• Working closely with the COO/CFO to ensure BD strategy and execution plan(s) are developed
• Perform initial scientific evaluation of external opportunities across all stages of development and play an integral role in the transaction team supporting licensing deals and/or acquisitions of assets
• Own the overall execution of an evaluation project providing oversight to the transaction team involved in the project as well as cross-functional members

Knowledge:

• Business development experience within pre-clinical and/or clinical stage business development
• Requires demonstrated knowledge and understanding of pharmaceutical development and commercialization and business practices required to successfully bring drugs to market
• Knowledge of regulated environments
• Extensive scientific knowledge – ideally in stem cells, cell or gene therapy, gene-editing, immunology and / or other significant scientific training is required
• Working knowledge of intellectual property filings and contract negotiations

Skills:

• Manage multiple projects, deals, external and internal relationships in a cross-functional environment
• Ability to effectively manage as an individual contributor while also working cross functionally to execute on the BD strategy
• Deliver and produce outcomes consistently over time
• Strong interpersonal relationships to strengthen business relationships
• Effective creator and presenter of executive and functional information
• Strong business acumen and analytic and quantitative skills
• Utilizes experience, presentation and influencing skills to facilitate successful acquisition of the right opportunities
• Highly collaborative – demonstrates team and resource management skills; including the ability to manage team dynamics across companies.
• Ability to influence and lead cross-functional teams
• Help establish business development frameworks and best practices to ensure execution and cost efficiency
• Senior stakeholder management

Competencies:

• Consistently demonstrates competencies at the Director level: Strategic Agility, Learning Agility, Contributing to Effective Teams, Decision Quality, Dealing with Ambiguity, Managerial Courage, Managing with Vision/Purpose, Matrix working

Education and Related Experience:

• Required: BS/BA and scientific graduate degree (PhD or MD)
• MBA preferred, but not mandatory with:
• 8+ years working in business development, commercial and/or medical affairs area of pharmaceutical or biotechnology
• Experience in sourcing and evaluating pharmaceutical or biotech products, for potential licensing /acquisition
• Experience managing people, vendors or high performing teams.
• Excellent communication, presentation, and project management skills
• Independent, creative, highly motivated team player with a “nothing is impossible” attitude
• Able to perform in a fast-paced environment, manage multiple priorities simultaneously, and communicate complex information clearly

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-18 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description:

As a member of the Engineering team, the engineer shall support product development, process development, and manufacturing activities.  The employee shall utilize R&D methods and engineering techniques to design and develop new devices and combination products, develop processes, generate test systems, and improve manufacturing procedures.  Engineer shall also write and execute engineering protocols, and document reports and all elements necessary to launch products through design control.  This engineer shall be a thought-leader and subject matter expert in the organization, as evidenced by design concepts brought to fruition, novel processes, and/or patents, papers, or presentations.

Responsibilities:

1. Product Development: Lead, conceive, design, develop, test and refine cost-effective device or combination product prototypes to enable in vitro and in vivo Conduct studies to demonstrate feasibility of a product concept. Demonstrates deep insight regarding design intent and uses insight to drive product requirements and specifications.  Develop processes necessary to fabricate devices or combination products.  Develop and implement test methods for assessing the quality of in-process and finished products. Develop, execute and analyze design verification and validation studies, culminating in a design history file.
2. Technical Leadership: Lead research and development projects of strategic scope as key technical contributor. Recognized as a SME within ViaCyte on two or more substantive technical topics.  May coordinate activities of other personnel.  Work with other Engineering and cross-functional employees to achieve company and department milestones on time and on budget.  Maintain flexibility in a highly dynamic, cross-functional environment working with highly dedicated cross-functional colleagues in a culture focused on continuous improvement.
3. Manufacturing Support: Identify and implement improvements to manufacturing processes and process flow. Develop fixturing or other tools necessary for efficient manufacturing operations.  Conduct equipment preventative maintenance or qualification studies as necessary.  Conduct preclinical build operations as necessary.  Initiate, define, and execute process validation activities.
4. Quality Support: Write, amend and review SOP’s, batch records, raw material specifications, drawings and other documentation as required to support product manufacturing and quality control testing. Identify and drive resolution of non-conforming material (NCMRs) or corrective actions (CAPAs).
5. Clinical Support: Attend clinical procedures, document findings, synthesize, and drive advancements in clinical procedure necessary to achieve safety and efficacy targets.
6. Engineering / Scientific Acumen: Generate and present scientific data, including scientific papers and research reports. Work cross-functionally with scientists to generate preclinical study concepts, and work collaboratively to conduct study and report out results.

Education & Work Experience Requirements:

B.S., M.S., or PhD, mechanical, chemical or biomedical engineering or related field is required. Graduate degree strongly preferred.  Minimum of ten years of work experience in medical device development.

An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Experience/Knowledge/Abilities:

1. Strong verbal and written communication skills are required. Must be able to summarize and communicate technical concepts effectively.
2. Development experience of Class II or III implantable medical devices required. Familiarity with laparoscopic surgery strongly preferred.
3. Must possess fundamental and applied knowledge related to engineering principles and material science
4. Must possess fundamental understanding and application of statistical methods, experimental design and advanced data analysis.
5. Must work efficiently both independently and within a team, mentoring junior engineers as needed.
6. Experience with project management concepts and fundamentals
7. Must have experience with FDA Quality Systems Regulations, Design Controls, and ISO 13485-related documentation preparation.
8. Experience with cell culture, tissue culture, and cell handling strongly preferred.
9. Experience operating in clean rooms, aseptic handling practices preferred.
10. Advanced experience using CAD, SolidWorks preferred.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-21 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Job Description:

The Clinical Trial Manager II (CTM II) will serve as the primary study manager for any assigned clinical trial(s), acting as the main liaison across study team functions to ensure successful conduct of a clinical trial while exhibiting the ability to complete the majority of job responsibilities independently, only requiring oversight for complex trial manager activities.  The CTM II has had at least two years of experience in trial management or equivalent. In addition to serving as a mentor, the CTM II may also serve as a line manager for junior department members.  The CTM II role is the interim stage of the CTM career at ViaCyte, providing the opportunity for individuals to firmly establish their ability to drive assigned clinical trials while beginning to expand into program-wide responsibilities.

Responsibilities:

• Manage day-to-day overall operations of assigned clinical trial(s) with minimal need for mentor oversight. May require operational oversight of multiple trials.
• Lead, organize, assign, and track tasks assigned to clinical team members (e.g., consultants or in-house team) on assigned studies.
• Lead individual clinical trial team meetings for assigned studies.
• Drive timely enrollment of trial participants for assigned studies.
• Ensure creation of key study documents (e.g. informed consent document, case report forms, monitoring plan, and clinical study reports) via oversight of assigned team members.
• Establish and maintain assigned trial timelines to ensure alignment with the Clinical Development Plan.
• Ensure implementation of internal procedures to support ICH and GCP adherence on assigned clinical trial(s).
• Assist with establishing and updating internal procedures to maintain adherence to clinical trial operations.
• Create and track assigned study budget(s) to ensure spend remains within target.
• Ensure costs for assigned trials are captured in purchase orders and through review of trial-specific vendor invoices.
• Contribute to the identification, RFP and selection process for key trial vendors (e.g., CROs).
• Manage and oversee the performance of vendors (including CROs) for assigned clinical trials by acting as the primary interface.
• Facilitate the negotiation and contracting of vendor work orders for assigned clinical trials.
• Oversees site budget negotiations and contracting.
• Participate in meetings and conference calls with CROs, vendors, and cross-functional teams as required.
• Coordinate efforts by assigned clinical team member(s) to provision sites with investigational product, ancillary supplies, and associated documentation.
• Conduct training of site personnel on proper handling and surgical technique of investigational product.
• Provide content as requested for regulatory submissions related to assigned trials. May be required to author clinical sections of submissions.
• Author draft(s) of clinical trial protocols and amendments for assigned studies. Coordinate cross-functional review as required.
• Contribute information from assigned trials for inclusion in DSMB and CAB meeting materials.
• Coordinate creation and review of data listings by assigned team member for preparation of interim/final clinical study reports, DSURs, DSMBs, or as needed.
• Ensure potential subject safety issues are communicated to appropriate parties as identified.
• Provide program director with trial status updates and reports on assigned trial activities.
• Assist with additional tasks as assigned by departmental senior leaders.
• Line management responsibilities may be required.
• Mentoring of junior department members and/or new hire peers required.
• Oversight of consultant use and assignments for all assigned trials.

Education & Work Experience Requirements:

A bachelor’s degree and a minimum of four years of relevant clinical research experience are required.  A degree in the life sciences is preferred.

An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Experience/Knowledge/Abilities:

• Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements is required.
• Familiarity with diabetes, metabolic disease, cell therapy, and/or cutting edge translational medicine is strongly desired.
• Must possess several competencies, including diligence, self-initiative, an ability to effectively convey information, and a predisposition for being highly organized.
• Must have strong interpersonal skills including the ability to work with different personalities and styles, moderate and mediate, build and maintain consensus, and turn work assignments into value-added actions.
• Strong verbal and written communication skills are required including ability to organize and present concepts with written, oral, and technical media / approaches.
• Exhibits ability to influence and lead team members through both communication and role modeling, demonstrating the ability to speak persuasively and positively in public settings.
• Ability to work in a fast-paced environment on complex projects is critical, including strong skill sets in organizing workload, time management, identifying and implementing strategies for improving efficiency, and effective timely execution and completion of parallel tasks.
• Must be skilled in the Windows operating system, Microsoft Project, and Microsoft Office, including Word, Excel, and Power Point.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-XX and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position:

The Sr. Clinical Trial Manager (Sr. CTM) will serve as the primary study manager for any assigned clinical trial(s), acting as the main liaison across study team functions to ensure successful conduct of a clinical trial with independence while also providing significant contribution to program initiatives.  The Sr. CTM has had at least four years of experience in trial management or equivalent. The Sr. CTM is expected to serve as a line manager and mentor junior department members.  The Sr. CTM role is the ultimate stage of the CTM career at ViaCyte, providing the opportunity for individuals to firmly establish their role as a trial leader within the Clinical department, but also exhibiting the ability to provide program management.

Responsibilities:

• Ability to effectively manage day-to-day overall operations of multiple clinical trials independently and mentor junior CTMs.
• Lead, organize, assign, and track tasks assigned to clinical team members (e.g., consultants or in-house team) on assigned studies.
• Lead individual clinical trial team meetings for assigned studies.
• Drive timely enrollment of trial participants for assigned studies.
• Ensure creation of key study documents (e.g. informed consent document, case report forms, monitoring plan, and clinical study reports) via oversight of assigned team members and through directly authoring as needed.
• Establish and maintain assigned trial timelines to ensure alignment with the Clinical Development Plan.
• Ensure implementation of internal procedures to support ICH and GCP adherence on assigned clinical trial(s).
• Assist with development and implementation of internal procedures to support ICH and GCP adherence during clinical trials.
• Create and track assigned study budget(s) to ensure spend remains within target.
• Ensure costs for assigned trials are captured in purchase orders and through review of trial-specific vendor invoices.
• Ability to directly conduct the identification, RFP and selection process for key trial vendors.
• Manage and oversee the performance of vendors (including CROs) for assigned clinical trials by acting as the primary interface.
• Ability to independently negotiate and contract vendor work orders for assigned clinical trials. May assist efforts to establish service agreements with new vendors.
• Ability to directly conduct site budget negotiations and contracting.
• Participate in meetings and conference calls with CROs, vendors, and cross-functional teams as required.
• Coordinate efforts by assigned clinical team member(s) to provision sites with investigational product, ancillary supplies, and associated documentation.
• Independently conduct training of site personnel on proper handling and surgical technique of investigational product.
• Provide content as requested for regulatory submissions related to assigned trials. May be required to author clinical sections of submissions.
• Author draft(s) of clinical trial protocols and amendments for assigned studies. Coordinate cross-functional review as required.
• Ensure potential subject safety issues are communicated to appropriate parties as identified.
• Contribute information from assigned trials for inclusion in DSMB and CAB meeting materials.
• Ability to coordinate creation and directly review data listings (with assigned team members) for preparation of interim/final clinical study reports, DSURs, DSMBs, or as needed.
• Represent the Clinical team on key, cross-functional projects and teams to provide the input required for strategic decision-making.
• Provide program director with trial status updates and reports on assigned trial activities.
• Assist with additional tasks as assigned by departmental senior leaders.
• Line management responsibilities may be required.
• Mentoring of junior department members and/or new hire peers required.
• Oversight of consultant use and assignments for all assigned trials; may be required to establish consultant agreements.

Education:

A bachelor’s degree and a minimum of six years of relevant clinical research experience are required.  A degree in the life sciences is preferred.

An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Experience/Knowledge/Abilities:

1. Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements is required.
2. Familiarity with diabetes, metabolic disease, cell therapy, and/or cutting edge translational medicine is strongly desired.
3. Must possess several competencies, including diligence, self-initiative, an ability to effectively convey information, and a predisposition for being highly organized.
4. Must have strong interpersonal skills including the ability to work with different personalities and styles, moderate and mediate, build and maintain consensus, and turn work assignments into value-added actions.
5. Strong verbal and written communication skills are required including ability to organize and present concepts with written, oral, and technical media / approaches.
6. Proven ability to influence and lead team members through both communication and role modeling, demonstrating the ability to speak persuasively and positively in public settings. Well-versed in the functional expertise and expectations for core study team roles.
7. Ability to work in a fast-paced environment on complex projects is critical, including strong skill sets in organizing workload, time management, identifying and implementing strategies for improving efficiency, and effective timely execution and completion of parallel tasks.
8. Must be skilled in the Windows operating system, Microsoft Project, and Microsoft Office, including Word, Excel, and Power Point.
9. Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-46 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Summary:

The Head of Quality will be responsible for leading the growth of the quality management system and organization from early stage clinical development to Phase 2 and Phase 3 compliance including biological and medical device components of our combination products. The Head of Quality will collaborating with cross functional teams and leadership to provide creative and resourceful guidance to Management, the Quality Team and Project Teams to enable their timely and effective response to corporate goals. This position will provide inspirational leadership, ensuring growth opportunities for members of the Quality team, and upholding the highest standard of quality in conformance with internal and external guidelines and standards.

Responsibilities:

• Provide creative resourceful guidance to Management, the Quality team and Project teams.
• Manage, communicate across, up and down the organization as needed to inform and align priorities.
• Strong planning, organization, communication, presentation skills
• Manage, motivate, mentor direct reports and Quality team members, to higher levels of capability.
• Delegate responsibilities to Quality team members to promote engagement and growth.
• High level resource planning, ensure optimum utilization of resources available.
• Harmonize change management and design control for biologic and device components.
• Promote cGMP quality standards to be understood and embraced throughout the organization

Education & Work Experience Requirements:

• BS Biological Science or ChemE, with Quality related certification, advanced degree desirable
• Minimum 15-20 years’ Quality experience in Biopharma Quality/CMC
• Experience in developing and managing Phase 3 Quality System.
• Quality function leadership 30+ people required

Experience/Knowledge/Abilities:

• Ability to understand and communicate detailed scientific, quality, and regulatory information.
• Strategic thinker with the ability to influence at all levels of the organization.
• Strong inspirational leadership skills as a change agent.
• Highly organized, experienced risk assessment and risk management skills.
• Results-oriented focus on business objectives and goals.
• Quality Control management experience:
• Biologics experience. Cell therapy, medical device and/or combination product experience a plus.
• Direct experience with health authority inspections.
• Proficiency in Good Clinical Practices to support Clinical QA is desired, not mandatory.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-50 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Summary:

The Director of Investor Relations and Corporate Communications will be responsible for ensuring the company is appropriately and strategically positioned with analysts, investors, media, and all other relevant stakeholders. The role will support Management in developing the overall investor relations and corporate communications strategy and will be responsible for its execution. This individual will serve as one of the primary contacts with the investor community. The holder of this job will report directly to the Chief Operating and Financial Officer and will have significant exposure to senior leadership. This is an opportunity for the right individual to join a growing and dynamic organization. Come join our motivated team in making a difference for people living with diabetes!

Key Responsibilities:

• Work with COO/CFO and the Company Leadership team to develop and execute a comprehensive, best-in-class IR and corporate communications program, that aligns with company strategy and leverages a strong understanding of the investment, biotech and pharmaceutical communities to enhance the perception and visibility of ViaCyte
• Collaborate with various functions within ViaCyte, including finance, research, clinical, manufacturing, and regulatory, to develop consistent messaging and flow across all external collateral materials
• Manage interactions and communications with existing and potential shareholders and sell-side analysts; be responsive to information needs in compliance with company policies and securities regulations
• Collaborate with Company leadership to advance engagement with sell-side analysts, with the goal of securing coverage that recognizes our value and aligns with the corporate growth trajectory
• Gather real-time insights and analysis from analyst reports, investment sentiment and competitor activity, and effectively prepare ViaCyte leadership team/other internal stakeholders for external interactions
• Share market intelligence and investor perceptions of the company’s performance, and make sure investors are represented as a key stakeholder in the formation/execution of program strategy and communications
• Take leading role in drafting company overview sections for potential S-1 filing
• Partner with legal to develop securities filings/other disclosures and ensure compliance with company policies and securities regulations
• Oversee routine analysis of shareholder base, refinement of investor targeting strategy,
• Assist in development of strategic communications directed at the investment community related to corporate and product milestones, quarterly financial results, annual report and other disclosures, including press releases, conference call scripts, slides and Q&A
• Manage corporate overview presentation and the IR section of corporate website
• Manage Public Relations/Investor Relations Firm and external media relations
• Help organize, plan, attend and track Company road shows, presentations, speaking engagements and conferences
• Serve as primary contact and resource for fielding investor calls, requests for information, and shareholder questions
• Manage third party vendors and resources

Qualifications:

• BA/BS required; degree in the life sciences or finance preferred
• Requires 7+ years of experience, 2+ years of IR/Corporate Communications experience at a public biotech/pharma/life science company
• Requires excellent written communication and interpersonal skills, ability to draft engaging and impactful messages that are inspiring
• Strong planning, organizational, time and project management skills to prioritize and complete multiple assignments and coordinate workflow
• Ability to handle confidential information
• Advanced proficiency in MS Word, Excel, PowerPoint, and Outlook
• The professional presence and business acumen to relate as a trusted colleague to the Leadership team
• Must be able to anticipate needs, be proactive and exercise independent decision-making
• Must be able to perform in a high-pressure environment, and be able to meet tight deadline

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-09 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.