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Scientist - Cell Based Assays, Analytical Development

  • Location Del Mar, California
  • Job type Permanent
  • Reference BBBH116923

COMPANY:

Clinical-stage cell and gene therapy company

LOCATION:

San Diego, CA

TITLE:

Scientist, Cell Based Assays, Analytical Development

TYPE:

Direct-hire, full-time

RELOCATION ASSISTANCE:

Yes

ROLE RESPONSIBILITIES:

The Scientist, Cell Based Assays, Analytical Development will work with the Tech Ops team to develop and/or optimize cell-based asays for cell product characterization and release. The Scientist participates in laboratory activities to support process development, evaluate and develop new assay methods, and perform product characterization for CAR-T cell products. He/she is also involved in assay optimization, standardization, and transfer to internal or external QC labs.

This role includes performing assay development experiments, documenting methods and materials, writing SOPs/reports/CMC sections of IND, etc.

CANDIDATE REQUIREMENTS:

  • PhD in a relevant, scientific discipline
  • Expertise in cell-based assay development, potency assay development, analytical method development and CGMP guidance, preferably in the gene and cell therapy industry
  • Proven leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies and method qualification/validation
  • Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiments (DoE)
  • In depth experience in analytical techniques such as Flow cytometry, qPCR, ddPCR, Nanodrop, Fragment Analyzer, ELISA, Isoplexis, Nanostring, metabolic analysis, HPLC and potency assays
  • Experience with the development and optimization of NGS assay protocols a plus
  • Development, transfer, and qualification of cell-based assays for QC release testing and product characterization

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.