Sr. Process Engineer, Cryobiology - San Diego, CA

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Job description

Sr. Process Engineer, Cryobiology - San Diego, CA

Position Summary:

We are seeking an experienced and highly motivated individual to join our growing Process Development (PD) team that is dedicated to developing processes to manufacture off-the-shelf inducible pluripotent stem cells iPSC derived cellular-immunotherapies. The incumbent will lead activities to develop and optimize downstream manufacturing processes with specific focus to robustly formulate and cryopreserve iPSC derived cell products. S/he will serve as SME and participate in cross-functional teams to support R&D, MSAT, Manufacturing teams.

Key Responsibilities:

• Design and execute experiments to delineate impact of cryopreservation on target cell recoveries, proliferative capacity as well as in-vitro and in-vivo activity Implement strategies, technologies and materials using DoE approaches to formulations and cryopreservation protocols to optimize post-thaw cell recoveries
• Serve as an SME at cross-functional product team meetings with R&D, PD, MSAT, Analytical Development, Regulatory Affairs, Quality Control and internal/external Manufacturing
• Will train manufacturing Tech Transfer staff on the optimized cryopreservation process and at CDMO
• Author and review PD and Technical reports, relevant CMC sections of regulatory filings.
• Manage reports to support above goals and objectives

Basic Qualifications and Experiences:

• PhD in Cryobiology, Chemical Engineering, biological sciences or equivalent
• A minimum of 5 years experience developing processes to cryopreserve iPSC, Embryonic cells, NK and/or CAR-T cells
• Strong technical and experimental skills, innovative with collaborative teamwork across departments
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Proficiency in a septic techniques and mammalian cell culture
• Self-motivated, excellent time management, organizational, and proven problem-solving
• Outstanding written and verbal communication
• Prior experience managing Scientist and Development Associates

For immediate consideration apply today!

Questions? Please reach out to Dustin at

#TJP2021_SPEC

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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