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Process Development Scientist, Analytical Dev. - Raw Materials

  • Location Del Mar, California
  • Job type Permanent
  • Reference BBBH116753

COMPANY:

Clinical-stage cell and gene therapy company

LOCATION:

San Diego, CA

TITLE:

Process Development Scientist I/II, Analytical Development - Raw Materials (title dependent on experience)

TYPE:

Permanent, direct-hire

RELOCATION ASSISTANCE:

Yes

ROLE RESPONSIBILITIES:

This individual will work with the tech ops team to develop and/or optimize cell-based assays for cell product and raw materials characterization and release. The Process Development Scientist I/II will participate in laboratory activities to support process development, evaluate and develop assay methods, and perform raw material and product characterization for CAR-T cell products.

The Process Development Scientist I/II will be focused more on the raw materials - monitoring, version control, comparability analysis.

CANDIDATE REQUIREMENTS:

  • PhD in a relevant, scientific field
  • The ability to develop analytical assays for characterization of critical raw materials using molecular biology techniques (primer design, PCR, NGS).
  • Experience in cell-based assay development, potency assay development, analytical method development and CGMP guidance, preferably in the gene and cell therapy industry.
  • Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiments (DoE).
  • Experience in analytical techniques such as qPCR, ddPCR, RT-PCR, Fragment Analyzer, Flow cytometry, ELISA, HPLC, SDS-PAGE, SPR, Nanodrop.
  • Experience with the development and optimization of NGS assay protocols a plus.
  • Prior experience with CAR-T manufacturing process (leukopak processing, T cell isolations, use of Prodigy) is a plus.

If you meet the requirements above and would like to be considered for this position, apply on-line now to be contacted with further details. This is not a fully remote role.