Careers at ViaCyte

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

Incumbent will organize, supervise and 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 non-routine development activities. This is a full-time position.

Position Requirements

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.

Position Responsibilities

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

Education

A college degree in a biological or engineering science is required.
Minimum of 10 years 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 2020-26 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 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 support the development of new surgical procedures, write and execute engineering protocols, and document reports, and all elements necessary to launch products through design control.

Requirements

1. Product Development: Conceive, design, develop, test, and refine cost-effective device or combination product prototypes to enable in vitro and in vivo testing. This includes supporting the development of new surgical procedures. Conduct studies to demonstrate the feasibility of a product concept. Define 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. Project Management / Leadership: Lead projects of small to moderate scope as a project manager. May coordinate activities of other junior 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 and define 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 procedures 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.

Experience

1. Strong verbal and written communication skills are required. Must be able to summarize and communicate technical concepts effectively.
2. Must be skilled in identifying complex scientific problems and experimental hurdles, and in solving those problems.
3. Class II or III medical device or combination product experience required.
4. Must be proficient in performing independent research under minimal supervision and within short timelines.
5. Experience with statistics, experimental design, and data analysis fundamentals
6. Must have experience with FDA Quality Systems Regulations, Design Controls, and ISO 13485-related documentation preparation.
7. Experience with cell culture, tissue culture, and cell handling strongly preferred.
8. Strong theoretical knowledge of materials and mechanics preferred.
9. Experience operating in clean rooms, aseptic handling practices preferred.
10. Advanced experience using CAD, SolidWorks preferred.

Education

B.S., M.S., or Ph.D. in chemical, mechanical, biomedical engineering, or related field is required. Minimum of five 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.

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 2020-12 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, 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, 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

The Senior Clinical Trial Manager will assist and work in collaboration with the Director, Clinical Development (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:

• Effective management of day-to-day operations of multiple clinical 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
• Establish and maintain assigned trial timelines to ensure alignment with the Clinical Development Plan
• Drive timely enrollment of trial participants for assigned studies
• 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 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.
• Participate in meetings and conference calls with CROs, vendors, and cross-functional teams as required.
• 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
• Provide program director with trial status updates and reports on assigned trial activities.
• Coordinate efforts by assigned clinical team member(s) to provision sites with investigational product, ancillary supplies, and associated documentation.
• Author draft(s) of clinical trial protocols and amendments for assigned studies. Coordinate cross-functional review as required.
• Provide content as requested for regulatory submissions related to assigned trials. May be required to author clinical sections of submissions
• 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.
• 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 thru directly authoring as needed.
• Ability to coordinate creation of and directly review data listings (with assigned team members) for preparation of interim/final clinical study reports, DSURs, DSMBs, or as needed.
• Mentoring of junior department members required. Line management responsibilities likely required.
• Oversight of consultant work assignments for all assigned trials; may be required to establish consultant agreements
• Assist with additional tasks as assigned by departmental senior leaders Overnight travel required as much as 10%

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

This position requires a bachelor’s degree, life sciences preferred, and a minimum of 3 years of biotechnology or industry related project management experience are required. An equivalent combination of education and experience is sufficient to successfully perform the job duties is acceptable.  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 2020-31 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, 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

The Senior Data Manager will assist and work in collaboration with the Clinical Development Team, to ensure timely completion of program activities. This is a full-time position.

• Lead experience managing at least 3 studies simultaneously
• Will be primary point of contact to the wider clinical trial team for clinical trial data related matters
• Responsible for coordination of clinical data acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting
• Will participate in development of budget and timelines for client projects
• Responsible for CRF development based on protocol review
• Creation and/or review of data management plans, database specifications, edit check specifications and data entry guidelines
• Responsible to work directly with EDC developers in the development of quality and timely Electronic Case Report Forms (eCRFs); Centralized system and EDC system setup including UAT
• Responsible for ongoing data review and query management
• Receipt and archive of clinical trial data and/or data management documentation
• Responsible to coordinate coding for adverse events and concomitant medications
• Perform all DM responsibilities in accordance with company guidelines and Standard Operations Procedures and appropriate industry and regulatory standards and Good Clinical Practices.
• Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing data management services on behalf of Viacyte

Requirements:

• BA or BS in a life science, computer science, or related fields
• Minimum 7 years of experience in Data Management within the pharmaceutical/biotech industry
• Minimum 3 years in a Lead Data Manager role
• Ability to prepare complex data models unassisted and understand and model complex knowledge-intensive processes.
• Understanding of current industry standard best data management practices
• Familiar with the most common standard coding dictionaries and processes
• Strong initiative, excellent interpersonal and communication skills

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.
• 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 2020-30 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 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 will assist and work in collaboration with the Clinical Department to ensure
accurate and timely provisioning of supplies in support of clinical trial enrollment and study visit procedures.
• 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
(10%) 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 onhand
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.
Requirements
• 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.
• Candidates must be skilled in Windows, Microsoft Excel, Microsoft Office, and web-based tracking systems.
• Candidate must be willing to occasionally (10%) work night-shift hours.
• Candidate must be located within commuting distance of San Diego.
• Ability to make sound decisions despite intangible variables.
• Ability to work under stressful deadlines.
Laboratory and office space requiring adherence to standard safety practices, with possible exposure to chemicals, blood borne pathogens, and other risks typically associated with working in the administrative department of a biological sciences research facility.
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 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 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 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, 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 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 Talent Acquisition Specialist will develop and implement recruiting strategies to fulfill the hiring and staffing needs of the organization. As part of the HR team, this role is instrumental in creating a strong talent pipeline to support the organizations current and future growth. This individual will understand and identify hiring needs, actively source and screen, interview and hire top talent in partnership with hiring managers.

Requirements

• Develop, facilitate and execute all phases of the recruitment process including but not limited to: recruitment planning, sourcing, screening, interviewing, selection and all administrative support functions.
• Manage all job requisitions in accordance with the hiring plan, liaising with hiring managers to determine recruitment timing and needs.
• Continuously develop and actively build pipeline of candidates for multiple requisitions.
• Collaborate and consult with hiring manager to identify hiring criteria and draft detailed and accurate job descriptions and job postings.
• Screen and select qualified candidates.
• Coordinate interviews and logistics, conduct post-interview meetings, assist and provide guidance with the interviewing and selection process.
• Communicate and guide candidates through the process with the highest level of customer support.
• Collaborate with hiring manager and HR Director during the offer process to prepare offer of employment.
• Ensure compliance with federal, state and local employment laws and regulations, and company policies.
• Stay informed and up to date with trends and/or technology as it relates to recruitment and/or hiring practices.
• Recommend new methods, policies or procedures to continually improve efficiency of recruitment and hiring processes.
• Serve as employment brand ambassador and establish professional relationships both internally and externally.
• Participate and/or lead projects and initiatives as related to Talent Acquisition and/or overall HR goals and objectives.
• Perform other related duties as required and assigned.

Qualifications

Educational Background:

• Bachelor’s degree in Human Resources, Business Administration, or related field and a minimum of 5 years of experience in managing all phases of recruitment and hiring processes. An equivalent combination of education, training and direct experience sufficient to successfully perform the job duties as listed above is acceptable.
• HR certification and active affiliation with appropriate Human Resources networks and organizations is a plus.

Experience/Knowledge/Abilities:

• Thorough working knowledge of applicable laws, regulations and best practices applicable to hiring and recruitment.
• Ability to work independently and proactively, with minimal instruction and supervision, while working in a fast-paced environment with multiple deadlines and frequently changing priorities.
• Superior oral, written, and interpersonal skills including ability to communicate effectively with people both internally and externally.
• Independent thinker with excellent organizational skills, with solid follow-up and follow-through and strong attention to detail.
• Excellent time management skills with a proven ability to consistently deliver quality work and meet deadlines.
• Ability to perform duties with integrity, professionalism, and strict confidentiality.
• Proficient with Microsoft Office Suite and familiarity with applicant tracking software and/or other recruitment systems. Implementation of ATS system a plus.
• Biotech/life science experience a plus.

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: 2021-06 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 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

Perform a broad range of tasks in the support of cGMP and R&D activities related to the robust, reliable, and cost-effective purchase and distribution of materials. Manage vendor engagement, materials logistics, inventory control, and shipping & receiving.  This position includes hands-on and managerial participation including Plan and implement activities related to the timely, cost-effective procurement, inventory control, planning and quality of GMP and R&D materials.

• Develop, implement, and maintain systemic policies, procedures, and material control systems to reduce costs, streamline procedures, and implement solutions.
• Ensure the availability of GMP materials in the supply chain, as scheduled, and the maintenance of inventory at minimum acceptable levels.
• Responsible for vendor management including sourcing and supplying raw materials, utilities and outside services, as well coordinating global procurement efforts.
• Coordinate with finance/accounting on matters involving inventory-carrying costs.
• Plan and review requirements for acceptable GMP inventory.
• May assist with the establishment and maintenance of the GMP production control system.
• May work with customers in auditing customer inventory levels and with internal and external vendors to comply with inventory policies.
• Select, develop, and evaluate personnel to ensure the efficient operation of the function.

Qualifications

Education

• A college degree or certification in the area of supply chain, materials management, or logistics is preferred.
• 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.

Requirements

• Engagement with vendors to provide 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 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.

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: 2021-10 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:

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:2021-01and 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.