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
- 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.
- Lead continuous improvement initiatives with high complexity and impact to ViaCyte’s cell drug substance manufacturing paradigm.
- Participate in the evaluation of new technology (closed processing and process automation) for introduction into GMP cell drug substance manufacturing.
- Design studies, author protocols and reports for process characterization studies for the growth and differentiation of hESCs.
- Provide technical leadership by acting as a communication channel between cross-functional groups, company operations, and external partners.
- Perform cleaning and maintenance activities required to ensure a contamination-free environment.
- Support general laboratory and equipment maintenance as required.
- 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.
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.
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 email@example.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.
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.