Senior Process Engineer, Cell Therapy - California, United States - GQR

Description

OVERVIEW:

We are actively seeking a motivated Senior Process Engineer with a specialization in cell therapy to join our client's Process Development team. This hands-on laboratory position will drive the development of a novel engineered T-cell manufacturing process. Your duties will include evaluating technology and process improvements, executing comprehensive process scale-up, and playing a pivotal role in establishing a commercially viable process. Additionally, you will be essential in conducting process characterization and collaborating with MSAT for seamless technology transfer in a cGMP-compliant environment. The ideal candidate will serve as the process subject matter expert in cell expansion, isolation, cryopreservation and final formulation for clinical manufacturing for cell therapies, bioprocess development, and cGMP manufacturing.

RESPONSIBILITIES:

• Serve as process SME for a novel engineered T-cell program
• Perform scale-up/scale-out of processes developed in R&D for progress into early and late phase clinical manufacturing
• Develop and optimize unit operations for automated cell isolation, washing, cryopreservation
• Perform product characterization to establish critical process parameters and monitor critical quality attributes
• Support in-process and final product analytical testing using cell-based assays
• Works cross-functionally to drive innovation for T-cell production in a GMP setting.
• Collaborate with MSAT team for tech transfers to external manufacturing sites
• Works cross functionally and in close collaboration with R&D and MSAT teams for refining product characteristics and process operations in GMP and non-GMP settings
• Draft technical sections to support regulatory filings
• Draft, review, and approve technical documentation including reports, process descriptions, SOPs, and MBRs
• Leads process monitoring during process development and continues to support MSAT during manufacturing
• Assist with PD lab buildout including equipment evaluation, program optimization and purchase

QUALIFICATIONS:

• B.S. in a biological science, chemical engineering or other relevant discipline with 5+ years of relevant experience in cell therapy development
• Experience with closed systems like CliniMACS Prodigy, G-Rex, Xuri and automated cell washers and concentrators like the Rotea, Sefia, Cue or equivalent
• Well versed with cGMP requirements and working in a regulated environment
• Working knowledge of statistical design of experiments (DoE)
• Excellent technical written and oral communication skills
• Strong organizational and record keeping skills.
• Experience with flow cytometry, PCR and protein detection preferred