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

Position Description

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

Requirements

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

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

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

Education

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

Application Procedure

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

Policy

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

Company Overview

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

Position Description

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

Essential Duties & Responsibilities

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

Experience Required

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

Education

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

Application Procedure

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

Policy

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

Company Overview

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

Position Description

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

Essential Duties & Responsibilities

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

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

Experience Required

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

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

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

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

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

Education

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

Application Procedure

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

Policy

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

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

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate 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 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 2021-48 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

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

Company Overview

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

Position Description

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

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

Knowledge:

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

Skills:

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

Competencies:

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

Education and Related Experience:

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

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2021-45 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

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

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

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

Position Description:

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

Responsibilities:

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

Education & Work Experience Requirements:

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

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

Experience/Knowledge/Abilities:

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

Application Procedure

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

Policy

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

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

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 Associate II 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 Associate II will communicate and interact with cross-functional teams by providing support in the following activities: maintenance of supplier files, internal/external audits, batch record/receiving reports review, data entries, quality incidents follow-up, and other quality activities that may be assigned by Quality Management.

Essential Duties & Responsibilities

1. Provides support in maintenance of supplier, internal audit, training files, monitoring of change notifications from suppliers, etc.).

1. Responsible for SOP revisions as necessary.
2. Reviews batch records and ensures that the review observations/comments noted during review are documented and communicated to the appropriate personnel to prevent future document errors/discrepancies.
3. Conducts internal audits to maintain compliance with ViaCyte procedures and applicable regulations and ensure active follow-up on findings/recommendations including CAPAs observed during the audits.
4. Provides support by performing line clearances and QA verification of critical process steps during manufacturing.
5. 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.

• 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.  A certification in a quality discipline (e.g., CQA) is a plus.
• A minimum of 3-5 years of relevant work experience in biologics or pharmaceutical, combination product or medical device 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 2021-44 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 

This role works with the Technical Operations team to develop and/or optimize methods to advance the characterization and release testing for a cell-based therapy product candidate designed to treat diabetes. The role includes independently performing assay development experiments, carefully documenting methods and materials, interpreting test results, writing SOPs and reports, and communicating findings. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in process and analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment.  

This is a full-time position located in San Diego, CA and is not eligible for relocation 

Essential Duties & Responsibilities 

• Design and execute exploratory experiments to better understand and define CQAs of the PEC drug substance and combo product. 
• Develop or adapt analytical methods, and support their transfer and qualification for product release and stability testing, and/or process development and product characterization. 
• Leverage Design of Experiment (DoE) to better understand methods and materials used in support of method qualification and validation. 
• Perform risk and gap assessments for analytical methods, and aim to enhance compliance and robustness. 
• Independently research, plan and execute experiments, and analyze data to determine the next course of action. Summarize and make recommendations to internal and inter-departmental stakeholders, and clearly document study outcomes and conclusions in reports. 

• Perform analytical testing (e.g. gene expression, bioassays, flow cytometry) of GMP and non-GMP samples, and maintain required documentation according to departmental policy to support product release and process development, respectively. 
• Ensure adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of analytical data to support regulatory filings.  
• Regularly read and engage colleagues in discussions regarding relevant scientific literature, and present experimental results to the workgroup. 
• Perform analytical equipment maintenance/qualification; maintain a safe and efficient workplace, following safe lab practices, participating in lab organization, housekeeping, and maintenance activities. 
• Support the training of junior team members, as needed.
  

Experience Required 

• Expertise in cell-based assay, potency assay, and analytical method developments. cGMP guidance preferably in cell therapy industry. 
• In depth experience in analytical techniques such as flow cytometry, qPCR, ddPCR, Nanodrop, ELISA, NanoString, metabolic analysis, mass spec, RNA-seq, and potency assays. 
• Proven leadership in method optimization, analytical control strategies and method qualification/validation. 

• Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiment (DoE). 
• Ability to interpret and apply regulatory guidance and best practices for analytical method development and qualification/validation. 
• Experience with aseptic technique, and strong bench skills are required. 
• Knowledge of stem cell biology and/or developmental biology is desired. 
• Effective and professional communication skills, written and oral, and aptitude for problem solving and technical writing. 

• An eagerness to learn and continuously improve, and a dedication to quality. 
• 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.   
• Ability to work independently and as a team player in a fast-paced team environment, meet deadlines, and adapt to rapidly changing priorities across multiple projects in accordance with departmental and company objectives. 
• Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel. Experience with statistically programming or software a plus. 
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.
  

Education 

• A Ph.D. degree in a relevant scientific discipline (e.g. molecular biology, biochemistry) and a minimum of five years industry experience in analytical development and Quality Control.  
• 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 – 54 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

Under regular supervision, incumbent shall establish and maintain quality document control systems for the manufacture of the Company’s products.  Exercise frequent independent judgment; within agreed upon limitations, make administrative decisions and take-action based on knowledge of company’s organization, policies, procedures, and personnel.

Essential Duties & Responsibilities

• Manage a wide-range of quality documentation and records in order to support the areas of Quality Assurance, Quality Control, Manufacturing and R&D.
• Format controlled documents according to approved templates.
• Administrate electronic quality system software, including Document Change Control.
• Reconcile and distribute controlled documents.
• Establish electronic and hard copy filing systems for controlled documents.
• Create and maintain electronic databases which will facilitate efficient sorting and retrieval of laboratory data.
• Assist with administration of Company’s safety program, including scheduling training sessions and maintaining safety related documentation.

Experience Required

• Strong written and verbal communication skills.
• Understanding of Good Documentation Practices, Good Manufacturing Practices and Good Clinical Practices for documentation control requirements.
• Excellent Microsoft Office skills are required, including proficiency in Word, Excel, PowerPoint.
• Experience with creating electronic databases is strongly preferred.
• Knowledge of electronic quality system software.
• Must possess mobility to work in laboratory and office settings and to use equipment commonly found in these environments.
• 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 and Work Experience

• At least a high school diploma or an AA degree.

• At least 1-2 years of experience related to high-level administrative functions with document control in biotechnology, pharmaceutical, and/or medical device industries.

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 2021-28 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.

Position Description

This role supports our growing Analytical Development Team within Technical Operations to advance the characterization and release testing of a cell-based product candidate designed to treat diabetes. The role includes driving the analytical development strategy as well as managing the analytical testing to support product release, stability and characterization. The ideal candidate has a proven track record of successfully leading people and projects, demonstrated skill set and knowledge in analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment.

This is a full-time position located in San Diego, CA and is not eligible for relocation. 

Essential Duties & Responsibilities

• Provides and leads strategic leadership for analytical development to support the characterization and define the control strategy of a cell-based candidate product.
• Identifies critical quality attributes (CQA) for which controlled assays must be available for lot release and stability, and other attributes which require characterization assays.
• Directs implementation of novel, cell-based and genetic analytical methods to test process intermediates, drug substance, and drug product during process development.
• Manages a team to perform the Quality Control (QC) testing (e.g. gene expression, bioassays, flow cytometry) of GMP samples for product release, and non-GMP samples for research and process development.
• Employs quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions for clinical phase-appropriate assays.
• Independently researches, plans and executes experiments, and analyzes data to determine the next course of action. Summarizes and makes recommendations to internal and inter-departmental stakeholders, and clearly document study outcomes and conclusions in reports.
• Supports specification setting, qualification, and validation of assays for product release and stability testing, as well as technical transfer of assays to the QC laboratory.
• Ensures adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of analytical data to support regulatory filings.
• Regularly reads and engages colleagues in discussions regarding relevant scientific literature, and presents experimental results in team and company meetings.
• Supports the development of team members.

Experience Required

1. Expertise in cell-based assay and analytical method development, potency assay development, and cGMP guidance, preferably in the cell therapy industry.
2. In depth experience in analytical techniques such as flow cytometry, qPCR, ddPCR, Nanodrop, ELISA, Nano String, metabolic analysis, mass spec, RNA-seq, and potency assays.
3. Proven leadership in method optimization, analytical control strategies, and method qualification/validation.
4. Experience successfully managing people and projects.
5. Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiment (DoE).
6. In-depth knowledge of FDA and GMP guidelines, and ability to interpret and apply the guidance and best practices for analytical method development and qualification/validation.
7. Knowledge of stem cell biology and/or developmental biology is desired.
8. Effective and professional communication skills, written and oral, and aptitude for problem solving and technical writing.
9. An eagerness to learn and continuously improve, and a dedication to quality.
10. 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.
11. Ability to work independently and as a team player in a fast-paced team environment, meet deadlines, and adapt to rapidly changing priorities across multiple projects in accordance with departmental and company objectives.
12. Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel. Experience with statistically programming or software a plus.
13. Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

Education

A M.S. degree in a relevant scientific discipline (e.g. molecular biology, biochemistry) and a minimum of ten years industry experience in analytical development and Quality Control. 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: 2021-58 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.

Position Description

We are currently seeking a Quality Control Manager to work in both laboratory and cleanroom environments under strict SOP’s. This position will provide supervision of QC associates working as part of the QC team who are responsible for environmental monitoring, routine lab maintenance, data reporting, and date trending analysis. This position will manage the QC interface with manufacturing, by providing quality verification support of manufacturing processes.

Responsibilities for supervising QC Associates include: periodic training and proficiency assessments, developing and maintaining a culture of ownership and accountability, scheduling, sampling using EM equipment, sample handling, reporting results with clear accurate and complete documentation, maintaining database of results, investigation of OOS’s, and determination of root cause as appropriate.

This is a full-time position located in San Diego, CA and is not eligible for relocation.

Essential Duties & Resposibilities

The ideal candidate must be able to create, revise and update standard operating procedures as needed for performance, training and proficiency assessments and be knowledgeable of current GMP guidelines for EM including relevant FDA, EU GMP, and USP chapters and have experience with cleanroom validations, protocol writing and execution. Candidate must also have experience with handling, shipping, and tracking testing samples. Other responsibilities include quality review and release of all incoming GMP materials; inventory control management and preventive maintenance activities; raw material, in-process and lot release sample handling; and providing quality oversight of manufacturing processes. Routine QC analytical testing experience preferred, as well as development of testing and analysis methods and procedures in accordance with established guidelines for the approval of raw materials, in-process items and finished product.

A hands-on approach is required for most job tasks, such as environmental monitoring. Knowledge and experience with aseptic technique is required. The ideal candidate is self-motivated, detail oriented, resourceful, flexible and able to handle multiple priorities at once. Flexibility to handle shifts in manufacturing schedules is essential. Weekend work will be required due to the biological nature of the products.

Experience Required

• Experience in an aseptic manufacturing clean
• Experience performing testing in a regulated laboratory environment (cGMP) is
• Experience in handling of biological/raw
• Experience with analytical laboratory testing
• Experience with using USP compendial
• Experience with sample handling, shipping, tracking and
• Experience writing and following SOPs with adherence to good documentation practices is
• Experience in developing and validating test methods is
• Ability and willingness to perform a wide variety of tasks – from those which are routine in nature to those which require independent thought and
• Must be highly detail oriented, maintain accurate records, perform data analysis, and communicate results through written and oral
• Able to troubleshoot, solve difficult problems, and develop process
• Must be skilled in the Windows operating system and Microsoft Office, including Word and
• Ability to work well in a team
• Must be available to occasionally work weekend
• Authorized to legally work in
• Able to lift and move up to
• Strong written and oral communication

Education

• Preferred Education: BS or higher in biology, or related
• Additional Eligibility Qualifications: Minimum of 5 years working experience in a quality control or environmental monitoring supervisory position in a biotechnology or pharmaceutical

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: 2021-17 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.

Position Description

• Reports to the VP of Quality with a “dotted line” communication link to the VP Clinical Development (VP CD).
• Plans and execute activities according to the Good Clinical Laboratory Practices (GCLP) Quality Plan, and Good Clinical Practices (GLP) Quality Plan developed and maintained by the VP Quality in collaboration with the VP Clinical Development (VP CD), in accordance with Good Clinical Practices (GCP) and Good Clinical Laboratory Practices GCLP).
• Provides initial and quarterly gap analyses for GCP and GCLP.
• Provides Quarterly Key Clinical Quality Metric updates to Sr. Management.
• Communicates report findings and recommendations to the clinical organization through the VP CD, and follows responses to findings to ensure they are effectively implemented.
• Ensures that methods are established to help ensure the compliance and quality of clinical studies conducted by ViaCyte.
• Responsible for initial and periodic qualification of vendors, including contractors, contract services, and CROs.
• Responsible for ensuring that adequate policies and procedures are in effect to secure appropriate collection, storage, testing, reporting and tracking of clinical lab samples including tissues and clinical fluids by vendors or ViaCyte laboratories.
• Works closely with Clinical Operations, Regulatory, Quality, Information Technology, and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities.
• Recommends continuous improvement projects using industry Guidelines, national and local regulations, along with ViaCyte Clinical and Quality policies and procedures for the conduct of clinical trials and performance of internal and external audits.

This is a full-time position located in San Diego, CA and is not eligible for relocation

Essential Duties & Responsibilities

• Develop and maintain GCP compliant processes which ensure that ViaCyte clinical trials are conducted according to applicable regulatory standards.
• Plan, conduct and manage auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, agency regulations.
• Lead in identifying non-conformances, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols.
• Assist with management of contract auditors and conducting vendor audits.
• Develop and present GCP related training to internal clinical functions as required. Participate in the review and validation of technology products (e.g., software).
• Provide GCP guidance to internal stakeholders or Study Management Teams, as required.
• Ensure GCP inspection readiness in conjunction with Clinical Development management and represent GCP QA as subject matter expert during regulatory audits
• Support special projects requiring QA input.
• Perform other related duties as assigned.

Experience/Knowledge/Abilities

• Knowledge of the conduct and operation of clinical trials according to GCP and GLP application to clinical trial samples.
• Familiarity with electronic applications (e.g., Veeva) for TMFs, CSRs, TFLs.
• Experience including external/CRO, clinical/regulatory and document auditing highly desirable.
• Demonstrates strong analytical, problem solving skills.
• Strong communication skills in English, in written, verbal and presentation modes, are required.
• Must be skilled in Microsoft Office, including Word and Excel.
• Detail oriented, good organizational traits
• Self-motivated, with strong leadership abilities.
• Must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.
• Familiarity with applicable biological drug and medical device regulations and safety guidelines issued by health authorities and standards agencies.
• Ability to project a positive constructive attitude in communications to inspire cooperation and teamwork among peers and management members.
• In-depth knowledge of ICH, US, and EU GCP and GLP standards.

Education & Work Experience Requirements  

• Bachelor’s Degree from an accredited college or university.
• At least 7 years’ experience in the Pharmaceutical Industry and or Medical Device Industry with at least 4 years GCP compliance responsibilities.
• Valid passport required to enable international travel for job responsibilities.
• Certification in Clinical Quality Assurance, Clinical Trial Monitor, or Clinical Trial Manager accreditation highly desirable.
• 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 – 60 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.

Position Description

We are currently seeking a QC associate to work in both laboratory and cleanroom environments under strict 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.

A hands-on approach is required for most job tasks, such as environmental monitoring.  Knowledge and experience with aseptic technique is required.  The ideal candidate is self-motivated, detail oriented, resourceful, flexible and able to handle multiple priorities at once.  Flexibility to handle shifts in manufacturing schedules is essential.  Weekend work will be required due to the biological nature of the products

This is a temporary position located in San Diego, CA and is not eligible for relocation

Essential Duties & Responsibilities

• Adhere 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.

Qualifications

• Minimum of 2 years working experience in quality control or environmental monitoring in a biotechnology or pharmaceutical company.
• Experience in an aseptic manufacturing clean room
• College degree in a scientific discipline or 5+ years’ work experience in quality control or EM environment.
• Experience in handling of biological/raw materials.
• Ability to work well in a team environment
• Strong written and oral communication skills
• Excellent record keeping skills and attention to detail
• Must be skilled in Microsoft Windows and Office, including Word and Excel.

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 – 43 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.