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28 days old

Sr. Process Engineer, Cryobiology - San Diego, CA

Kelly Services
San Diego, CA 92108
**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 DUSG877@kellyservices.com_**


**_\#TJP2021_SPEC_**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-11-01 Expires: 2021-12-02

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Sr. Process Engineer, Cryobiology - San Diego, CA

Kelly Services
San Diego, CA 92108

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