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 Supplies Associate is an integral part of our clinical team and will assist and work in collaboration with the Clinical Department to ensure accurate and timely provisioning of supplies and products in support of clinical trial enrollment(s) and study visit procedures. 

 Essential Duties & Responsibilities

• Manage various aspects of day-to-day clinical trial supply management as assigned.
• Responsible for completion and oversight of all investigational product (IP) requests across product candidate programs, including, but not limited to: IP manufacturing requests, tracking of all IP shipping and delivery, IP accountability logs, inventory reports and return of IP and samples.
• Maintain the master IP provisioning and implant scheduling calendar.
• Liaise with Manufacturing and Quality departments to ensure projected implant dates correspond with available department resources.
• Communicate with clinical teams to confirm surgical implant dates and the IP build request specifications.
• Submit IP build requests to Manufacturing and address inquiries from Manufacturing and Quality regarding requests.
• Arrange for IP delivery with Shipping and track/confirm receipt of IP at clinical sites. This may occasionally require night-time work hours to confirm receipt of IP in different regions of the world.
• Verify collection of IP acknowledgment of receipt from all clinical sites.
• Troubleshoot and mitigate courier and delivery delays with vendors to ensure timely delivery of IP.
• Track and maintain appropriate inventory levels of IP shipment materials.
• Perform data entry and maintain accuracy of the internal master IP accountability database.
• Maintain the master IP explant scheduling calendar in order to track and receive all explanted IP units and inform all necessary parties (e.g., clinical team, histology department) of product receipt.
• Receive and process ancillary supply requests from clinical sites. Involves putting together packages of ancillary supplies distributed by ViaCyte for new sites during study startup as well as re-supply of materials for active study sites.
• Creation of accurate packing lists for both IP shipments and ancillary supply shipments
• Ability to anticipate both internal ViaCyte and site supply needs based on enrollment projections and screening activity.
• Maintain supply vendor contact information and establish supply vendor POs/review invoices.
• Maintain and update ancillary supply tracking logs to ensure appropriate inventories of supplies are on-hand and provisioned to sites in accordance with the level of patient activity in a trial.
• 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.
• Ensure all study-specific IP tracking and accountability documentation is filed in the appropriate study Trial Master File.
• Assist study teams with final study IP accountability by providing accurate records of master trackers as requested.
• Train investigator sites on IP receipt, accountability, and return procedures as needed.
• Review and update Standard Operating Procedures (SOPs) related to IP management.
• Maintain effective communication with study teams throughout study cycle.

Experience 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 a plus.
• Strong organization and inventory management skills are required including the ability to track and monitor numerous details accurately.
• Skilled in Windows, Microsoft Excel, Microsoft Office, and web-based tracking systems.
• Able to work night-shift hours (as needed).

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: 2021-10 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

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 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: 2021-03 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, analyze supplier trends and coordinate improvement activities, maintenance of supplier files, monitoring of change notifications from suppliers, etc.). Presents supplier status to Quality Management.
2. Responsible for SOP development/revision and evaluation of their appropriateness in the development phase.
3. Assists in the review of 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.
4. 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.
5. Develop metrics on audit findings and provides report in preparation for Management Review Meeting.
6. 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.
7. Assists in the coordination and scheduling of Management Review Board (MRB), Change Control Board (CCB), and Quality System Incidents Review Board (e.g., deviations, NCMRs, OOS, etc.).

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 hr@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.