Careers at ViaCyte

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. We are an E-Verify Employer.

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. We are an E-Verify Employer.

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

Perform experiments and analyses related to culture of human pluripotent stem cells and development of a cell therapy product.

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

Essential Duties & Responsibilities

• Grow, passage, and differentiate human pluripotent stem cells using aseptic technique including protocol optimization.
• Analyze the progression of cell differentiation in vitro using real time gene expression using Nanostring platform.
• Executes, and interprets experiments, with a high degree of reliability.
• Conducts own experimental troubleshooting on routine problems.
• Performs basic statistical analysis of experimental data, where appropriate.
• Prepares protocols and written study reports.
• Surveys relevant scientific literature to maintain awareness of issues and trends within the field.
• Present studies effectively at internal Group/Department or Project Team research meetings.
• Performs other duties as assigned.
• Highly self-motivated and flexibility in working schedule to accommodate weekend work when necessary.

Experience Required

• Extensive Embryonic stem cell culture experience is required.
• Knowledge of stem cell biology and/or developmental biology is preferred.
• Experience with molecular biology techniques especially Nanostring, viability, cell death assays and ELISA is required.
• 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, primarily Word, Excel and PowerPoint.
• Strong verbal and written communication skills are required.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

Education

• A master’s degree in cell biology or a related field, and a minimum of five years of laboratory experience is required.
• 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 – 53 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify Employer.

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

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

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

Essential Duties & Responsibilities

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

Experience/Knowledge/Abilities:

• Demonstrated experience with aseptic cell culture methods, including cryopreserving, thawing and culturing cell lines is essential.
• Experience with cell-based assays (gene expression, flow cytometry, ELISA) is essential.
• Experience performing testing in a regulated laboratory environment (cGMP, cGLP, clinical lab scientist) is essential.
• 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 highly detail oriented, maintain accurate records, perform data analysis and communicate results through written and oral summaries.
• Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel.
• Strong verbal and written communication skills are required.

Required Qualifications:

• BS/MS in cell or molecular biology and a minimum of 3 years of laboratory experience is 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: 2021-63 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify Employer.

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

ViaCyte is seeking a highly motivated and talented individual to join the Process Development (PD) team in developing commercial production processes for a cell-based therapy to treat diabetes. This position is open to individuals that have experience supporting cell & gene therapy bioprocessing efforts at either cell therapy process engineer I, II, or senior levels. Under minimal supervision, the primary activities of the Cell Therapy Process Engineer will be to provide process science and engineering support for commercial GMP technology transfers, development studies, and continuous improvement projects for ViaCyte’s human embryonic stem cell (hESC) based cell therapy products. Additional activities include design-of-experiments (DOE), lab management, data entry, writing of technical reports, and support of other cross-functional projects.

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

Essential Duties & Responsibilities

1. Execute hESC and hESC-derived culture and analytical experiments under written protocols. hESC/hESC-derived culture will be performed using multiple platforms at multiple scales (e.g. multi-layer cell factories, roller bottles, bioreactors, etc.). Assay methods include, but are not limited to, design-of-experiments (DOE), flow cytometry, expression profiling, ELISA, and metabolite analysis.
2. Lead continuous improvement initiatives with high complexity and impact to ViaCyte’s cell drug substance manufacturing paradigm.
3. Participate in the evaluation of new technology (closed processing and process automation) for introduction into GMP cell drug substance manufacturing.
4. Design studies, author protocols and reports for process characterization studies for the growth and differentiation of hESCs.
5. Provide technical leadership by acting as a communication channel between cross-functional groups, company operations, and external partners.
6. Perform cleaning and maintenance activities required to ensure a contamination-free environment.
7. Support general laboratory and equipment maintenance as required.

Required Qualifications:

• BS/MS degree that included laboratory work in a Chemical Engineering, Mechanical Engineering, Biomedical Engineering or related field. Two to five years of laboratory experience in an academic, biotechnology, or pharmaceutical setting is preferred.
• Experience with mammalian cell culture and/or in a cGMP manufacturing/laboratory environment preferred.
• Experience with design-of-experiments (DOE), process design of scalable cell processing, media formulation, and bioreactor technologies.
• Experience with computational modeling platforms for process parameter prediction (e.g. fluid dynamics, mass transfer)
• 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 (e.g. JMP).
• 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.
• Equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Preferred Qualifications: 

The ideal candidate will have engineering experience with a cell and gene therapy bioproduction focus 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.

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: 2021-64 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

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

ViaCyte is seeking a highly motivated, experienced, and creative individual with expertise in cell therapy to be a key driver in developing high-yielding bioprocesses for cell manufacturing, and advancing process understanding in support of our clinical development efforts. This individual will be responsible for leading a team of scientists and engineers with the goal to develop and implement cell process improvements, including scale-up capabilities, per the departmental strategy and in line with corporate goals.

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

Essential Duties & Responsibilities

• Guide cell therapy process development to identify end-to-end solutions, with specific focus on cell expansion and cryopreservation to support allogeneic, off the shelf cell therapy products. Identify and implement solutions to address technical challenges in the manufacturing process to support short- and long-term manufacturing needs.
• Demonstrate new equipment and processes meet user requirements through collaboration with manufacturing and quality teams. Subject matter expert for custom equipment, performing qualifications as needed.
• Identify and characterize critical process parameters; perform risk assessments (e.g. pFMEA) to improve process robustness.
• Develop, tech transfer and implement cGMP manufacturing processes for cell therapy products meeting quality targets, and regulatory requirements. Provide ongoing technical support for manufacturing.
• Collaborate with analytical team to characterize impact of process changes on cell phenotype.
• Support supply of materials including cells and others for research, non-clinical, analytical development and technology transfer activities.
• Identify and vet CDMOs for external manufacturing of clinical drug substance, drug product and critical raw materials under GMP, in coordination with the Business team.
• Develop, in collaboration with vendors and CDMOs, a supply chain for all necessary GMP materials for manufacturing of drug substance and drug product.
• Build, coach, mentor and guide process development and cell engineering functions to become a high performing team.
• Develop and maintain budgets in collaboration with finance and program management.
• Author and review technical and scientific documents, and take responsibility of CMC section of regulatory documents. Take responsibility for study protocols and reports, validation documents, SOPs, and test methods.
• Establish strong relationships and collaborate closely across the organization, external CDMOs, and academic and commercial partners.
• Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
• Demonstrated track record with process development supporting early and late cell therapy manufacturing.
• Experience with technology transfer.
• Subject matter expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, cell biology/physiology.
• Knowledge of stem cell biology and/or developmental biology is highly desirable.
• Familiar with product characterization methods relevant to cell-based product (e.g. flow cytometry, PCR / qPCR, and ELISA).
• Familiar with FDA and EMA guidance documents relevant to cell therapy. Experience authoring CMC sections of regulatory documents (IND/BLA) and engaging regulatory authorities.
• Strong working knowledge of cGMP and quality systems requirements.
• Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.
• Demonstrated leadership skills and the ability to collaborate with and effectively influence others.
• Prior experience managing functional teams and representing function in CMC teams.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed above.

Required Qualifications:

• The ideal candidate will have a PhD in a relevant discipline (e.g. chemical engineering, biomolecular engineering, biotechnology) with a minimum 7years’ direct experience in cell therapy process research and development.
• Equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable. (Title and compensation will be commensurate with experience)

Preferred Qualifications: 

• 10-12 years of direct experience in cell therapy process development.

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: 2021-66 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify Employer.

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

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

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

Essential Duties & Responsibilities

• Coordinate and manage one or more cross-functional project teams to effectively deliver corporate objectives.
• Working with the Core Team Leaders, develop project scopes, plans and objectives to execute activities.
• Serve as the key point of contact for communications and coordination within the project team.
• Utilize project management tools and processes, such as project contracts, status updates, action and decisions logs and project review materials to support project execution, team coordination and management reviews.
• Establish and maintain collaborative relationships with cross-functional teams to efficiently manage project execution. Project stakeholders may include 3^rd party partners or customers.
• May provide direct or indirect supervision of junior project managers to execute related activities.

Experienced Required

• Minimum of 5 years project management experience with 3 years of experience leading project teams, preferably in a Clinical, Med Device or Pharma company.
• Experience with FDA approval and/or commercial launch of a medical device or pharma/biopharma product preferred.
• Proven written and communication skills and experience with Project Management processes, tools and templates.
• Solid organization skills, attention to detail and multi-tasking capabilities.
• Experience managing multiple projects in a cross-functional team environment.
• Strong working knowledge of Microsoft Office and project management software (Smartsheet, MS Project, or similar).

Education

• Bachelor’s or Master’s Degree in Engineering, Scientific or appropriate business field.
• PMP certification or equivalent (preferred)
• 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: 2021-68 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify Employer.

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

ViaCyte is seeking a highly motivated, experienced, and creative individual with expertise in cell therapy to be a key driver in identifying, developing and delivering new lines of products and developing new opportunities in various disease areas.

This individual will be responsible for leading a team of R&D scientists and engineers with the goal to develop and implement new cell therapy concepts, looking internally and externally for competitive opportunities.

This is a full-time position, reporting to the CTO and is located in our facilities in San Diego, CA.

Essential Duties & Responsibilities

• Lead the identification and development of new product programs, focused on cell therapies, supporting both internal initiatives and external collaborations.
• Provide scientific leadership, develop experimental plans and successfully execute program timelines with R&D collaborators.
• Provide scientific oversight and direction, decision‐making, problem‐solving and supervisory capabilities to program scientists.
• Demonstrate proof of concept in the identified opportunities in order to deliver a scalable product concept.
• Maintain and expand scientific knowledge in areas applicable to departmental function.
• Support research collaborations, corporate due‐diligence, and Business Development initiatives.
• Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
• Experience in developing new product candidates in various disease settings.
• Practical/technical experience in cell therapies or regenerative medicine.
• Demonstrated ability to bring new product ideas to the table.
• Ability to achieve results with colleagues of diverse functional expertise, skills, and priorities, in a matrix managed organization.
• Self‐motivation, excellent time management, organizational, and analytical skills and excellent written and oral communication skills.
• Ability to foster a strong team‐first environment and lead multiple teams.
• Passionate about results; goal-oriented with ability to generate high quality, on‐time results.
• Comfortable working in highly entrepreneurial environment.
• Belief in and adherence to the Company’s Vision, Mission and Values.
• Demonstrated experience building and leading exceptional teams.
• Outstanding written and verbal communication skills. Ability to effectively communicate scientific and technical concepts, program objectives, data analysis within a matrix environment.
• Direct supervision of scientists and engineers

Required Qualifications:

• The ideal candidate will have a PhD in a relevant technical discipline (e.g. cell biology, biomolecular engineering or biotechnology) with a minimum 7 years’ direct experience in cell therapy process research and development
• Equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable. (Title and compensation will be commensurate with experience)

Preferred Qualifications: 

• 10-12 years of direct experience in cell research and development

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: 2021-69 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify Employer.

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

Develop, perform and oversee the performance of testing methods designed to characterize a cell-based therapeutic product at various stages during the manufacturing process, up to and including release of the product for administration to patients.

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

Essential Duties & Responsibilities

• 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.
• Monitor and trend GMP Quality Control testing data to assure validity of test system results. Troubleshoot and remedy suboptimal performance of test systems.
• Perform and oversee product characterization testing in support of research, process development and manufacturing efforts.
• Oversee analysis of cell composition data. Report results. Advise internal customers regarding outcomes of testing.
• Supervise the work of one or more Assay Development Associates.
• Maintain instrumentation. Monitor instrument performance to assure optimal operation.
• Validate test systems and methods for use in the quality control of GMP-regulated manufacturing, as necessary.
• Develop additional test methods in response to internal customer requirements, as necessary.

Required Qualifications:

• A bachelor’s degree in biology or a related field, and a minimum of ten years of laboratory experience are required.
• 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: 2021-70 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify Employer.

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

Incumbent will perform a broad range of tasks in the cGMP manufacture of cells and combination cell therapy/device products for use in clinical and developmental studies.  This position includes hands-on participation including materials logistics, assisting in manufacturing operations, and may include non-routine development activities.

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

Essential Duties & Responsibilities

• Assist in manufacturing operations to produce GMP grade product to meet corporate goals.
• Assist in ensuring that there are sufficient materials available for all production runs or campaigns including media, small molecules, and growth factors.
• Provide hands on support for scale out/up and development activities as needed based on a demand plan.
• Understand, revise 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.
• Assist in maintaining GMP areas 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.

Experience Required

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

Education

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

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code: 2021-48 and your full name. Send to Careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

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

The Regulatory Affairs Manager will contribute to successful achievement of ViaCyte’s product development objectives through managing, evaluating and completing regulatory projects consistent with established timelines and goals. They will be responsible for the development and implementation of regulatory submission plans, authoring submissions, performing regulatory operations activities, and maintaining the regulatory files. The Regulatory Affairs Manager will provide assessments of product and process changes, and collaborate with development teams, peers and management with a positive constructive attitude in communications to inspire cooperation and teamwork.

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

Essential Duties & Responsibilities

• Author and submit routine submissions to Global Authorities and EU Legal Representative
• Assist in the development of Regulatory Submission Plans and timelines
• Assist in the authoring and review of moderate to complex regulatory submissions and associated support documentation
• Review change controls and provide impact assessments for minor changes
• Perform regulatory operations activities
• Maintain regulatory submission and correspondence files
• Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures
• Other duties as assigned

Required Qualifications:

• Bachelor’s degree in scientific discipline
• 2-5 years’ experience in pharmaceutical, medical device or biologics industry
• Minimum of two (2) years of experience in regulatory affairs
• Experience and knowledge in preparation of INDs, CTAs and supportive amendments and supplements (manufacturing, nonclinical, clinical) including experience with CTD/eCTD
• Working knowledge of FDA and ICH regulatory guidance and regulations
• Equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable

Preferred Qualifications: 

• Regulatory experience with drug/device or biologic/device combination products

• Experience in the Biologics or Biotech industry, ideally with Advanced Therapy products
• Working knowledge of Regulatory Operations and CTD/eCTD standards

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: 2021-71 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

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

As a member of the Facilities group, incumbent will perform a broad range of tasks in the support of Clinical Manufacturing, Device Manufacturing, and R&D operations at all ViaCyte facilities. Assigned tasks are expected to be routine in nature and performed with a minimal amount of oversight.

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

Essential Duties & Responsibilities

• Direct all facility related activities including building maintenance and improvement, environmental health and safety, validation support, security, and materials management support.  This may include management of multiple groups and staff.
• Complete GMP documentation as required for equipment and facility systems.
• Work in conjunction with Quality, Manufacturing and other functions to implement best practices, process improvements and to support audits.

• Ensure that facilities, utilities and equipment meet company needs and comply with government regulations and environmental, health and security standards.
• Be part of a rotating on call strategy to support MFG and R&D 24/7/365 operations.
• Must be skilled in troubleshooting mechanical, utilities and electrical problems and driving solutions to resolution in short timeframes.
• Must have hands-on practical experience with facilities and equipment maintenance and repair including cleanroom spaces.
• Must be satisfactorily skilled in Microsoft Office, including Word and Excel, Outlook, and demonstrate basic competence in working with electronic database software.
• Preference for candidates who have worked in a regulated (ISO, GMP, EMEA) industry where facilities and equipment must meet defined operational criteria with associated requirements for maintaining compliance documentation.
• Experience performing work in clean rooms preferred.

Required Qualifications:

• A high school diploma is required. A minimum of two years in the medical device manufacturing or pharmaceutical/biotech production environment is preferred.
• Additional certifications or training as applicable to this position
• Trade or vocational school certificate preferred / Equivalent military training.
• 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: 2021-72 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

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

The Talent Acquisition Specialist is responsible for full-cycle recruiting, working closely with the Talent Acquisition Manager and executing tasks with limited direction in a high-volume, fast-paced environment. This position achieves hiring goals by filling open positions with diverse, talented and qualified candidates. This requires entails sourcing, screening, qualifying and interviewing candidates. The Talent Acquisition Specialist also coordinates the interview process, facilitates offers and employment negotiations, completes all pre-employment references and screenings, all while ensuring the candidates have an exceptional recruitment experience and introduction to the company. A successful team member partners with the hiring manager and Human Resources representatives to ensure hiring needs are met while regularly communicating and providing updates to them throughout the process.

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

Essential Duties & Responsibilities

• In collaboration with the Talent Acquisition Manager, develop and administer recruiting programs by managing the full life cycle of the recruitment process including (posting, screening, interview, selection and closing process).
• Work with hiring managers to document requirements of open positions to accurately reflect job requirements. Complete an intake assessment with hiring managers to discuss expectations and ideal candidate qualities. Partner with Human Resources representatives as needed to complete job descriptions and review compensation expectations.
• Identify creative sourcing and recruitment strategies to find, pipeline and select top talent for current and future positions, while considering Diversity Equity & Inclusion objectives.
• Locate qualified, diverse, applicants using databases, searches, online job boards, networking, etc. Determine appropriate recruiting sources for advertising and posting positions that maximizes candidate response rate.
• Work with agencies, recruiting contractors and/or internet website representatives in the course of conducting employment advertising campaigns to promote the company image and brand.
• Pre-screen resumes and applications, perform initial phone interviews.
• Document and compile candidate evaluation and interview process. Keep candidates up to date on process.
• Maintain the requisition status and candidate status information accurately and timely in Applicant Tracking System. Generate reports for tracking recruitment metrics.
• Lead the interview process, including scheduling interviews, oversee preparation of interview questions and other hiring and selection materials, attending and conducting interviews with managers, directors, and other stakeholders.
• Complete reference checks and any other additional pre-employment requirements for each position.
• Collaborate with the hiring manager and/or other human resource staff during the offer process, identifying and recommending salary ranges, incentives, start dates, and other pertinent details.
• Negotiate complex offers and/or support hiring managers in finalizing offers.
• May provide performance feedback on all recruiting agencies/sources.
• Provide an efficient and high-quality candidate experience at every stage of the recruitment process.
• Attend and participate in college job fairs, community outreach, college relations, and other recruitment programs.

• Stay abreast of recruiting trends and best practices. Identify, recommend and implement process improvement changes and best practices.
• Ensure all screening, hiring, and selection is done in accordance with employment laws and regulations.
• Identify opportunities to increase employment brand recognition and partner with Communications team and Human Resources to update the careers page, social media outlets, and other platforms.
• Take initiative and thrive in a fast-paced and ambiguous environment.
• Agency or corporate recruiting experience in biotech, life science or pharmaceutical industries is preferred but not required.
• Strong sourcing ability utilizing job boards and social media.
• Solid ability to conduct different types of interviews (structured, competency based etc.).
• Hands on experience with various selection processes (video interviewing, phone interviewing, reference check etc.).
• Hands-on experience with recruiting software, as well as Human Resource Information Systems.
• Ability to communicate effectively, both verbally and in writing.
• Demonstrated ability to establish effective and cooperative working relationships built on trust.
• Excellent organizational and time management skills.
• Comfortable making decisions independently.
• Working knowledge of various job boards (LinkedIn Recruiter, Indeed, etc).
• Ability to manage a wide range of relationships with a variety of stakeholders.
• Proficient in Microsoft Office 365: SharePoint, MS Teams, Outlook, OneDrive, Excel, AdobeSign, DocuSign
• Deep understanding of employment laws and regulations.
• Familiar with a wide variety of sourcing avenues within the biotech, life science industry.
• Act as a point of contact and build influential candidate relationships during the selection process.
• Perform other duties as assigned.

Required Qualifications:

• Bachelor’s degree in Human Resources or related field, or equivalent work experience, required.

• 2 years of recruiting experience.
• Experience in the Bio-tech industry preferred.
• 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: 2021-73 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

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

Provides executive level administrative support to the Chief Science Officer (CSO), Head of Business Development, Head of Legal and other departments as needed.  Handles matters with strict confidentiality and meets short deadlines and manages priorities. Focus areas of work may vary based on individual needs of the manager and functional area.

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

Essential Duties & Responsibilities

• Provide executive support to three executives: Chief Scientific Officer, Head of Business Development, and Head of Legal to manage their time and coordinate requests including managing calendars that require a high level of coordination, attention to detail and sensitivity.
• Plan, organize, schedule and coordinate meetings and events with individuals or large groups including coordinating conferences, company meetings and guest visits, managing and setting agendas, research and recommendations on locations, room set up, refreshments, conference call dial-in instructions and audio-visual equipment.
• Answer, screen, respond and route calls independently when appropriate and in a manner that is professional, and is a positive reflection of the company.
• Prepare documents, meeting agendas, meeting minutes, presentations and spreadsheets
• Make travel arrangements and prepare itineraries for travel within the U.S. and internationally; change travel schedules, flights, hotels and rental cars.
• Review, compile and process business expense reports.
• Provide other general administrative support including, mail, filing, scanning, copying, etc.
• Collaborate with other company Executive Assistants and provide backup assistance to ensure seamless and high-quality level of support services for office & administrative needs throughout the organization.
• Other duties as assigned.
• Strong command of standard, professional office practices and procedures.
• Demonstrated experience managing multiple complex calendars for executives.
• Extensive experience in the planning, coordination, and execution of various types and sizes of meetings and events.
• Highly proficient with MS Office with ability to quickly learn and utilize various software applications to complete assigned tasks.
• Ability to make sound judgments and problem-solve creatively, resourcefully and nimbly in a fast-paced, changing environment.
• Clear and professional written and verbal communication skills.
• High attention to detail and quality of work, including thorough consideration for its method of delivery to end users.
• Strong sense for upholding confidentiality over various corporate, HR and other sensitive materials and data encountered during the course of work.
• Proactive, positive and customer service-oriented with thoughtful follow-through.

Required Qualifications:

• Bachelor’s degree or formal training and certification from a community or technical college in office management, executive assistant skills, or related field.
• Minimum of six years’ experience as an office administrator or executive assistant.
• 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: 2021-74 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

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.