Scientist - Cell Based Assays, Analytical Development
- Posted 27 April 2021
- Salary Up to £0.00 per annum
- Location
- Job type Permanent
- ReferenceBBBH116923_1619569071
- Contact NameBecky Krage
Job description
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.