Clinical and preclinical stages of development for genomic medicines for serious diseases (gene & cell therapy & genome editing)
Greater San Francisco area
Senior Scientist, Bioassay Analytical Method Development
Some assistance available
This individual will perform laboratory-based activities to design, develop and qualify analytical methods for the characterization, and release testing of the company's rAAV gene therapy, genome editing, and cell therapy products.
Ideal candidate will be experienced and should independently perform biological assays to measure potency, molecular based assay and characterization assays for product characterization.
The successful candidate will develop, qualify and method transfer phase appropriate molecular biology strategies for the lot release, stability, and characterization testing for gene therapy products. They will participate on cross-functional project teams (internal and cross department) and represent the AD function in a CMC sub-team representative capacity.
- PhD and post-doc experience in toxicology, pharmacology, immunology, or related discipline with 5+ years of pharmaceutical/biotech industry experience. Level based on experience
- In depth knowledge of understanding the mechanism of action (MoA) of biologics and experience in design, and development of mechanism of action (MoA) reflective bioassays using appropriate technologies, such as cell based, ELISA and enzymatic assays experience is required
- Knowledge of FDA, cGMP, and ICH regulatory requirements in the context of bioassay/potency assay development and qualification is desired.
- Experience and knowledge of QC and GMP regulations is essential.
- Experience with method transfer to both in-house QC and contract organizations (CDMO/CTOs) is required
- Extensive experience in cell culture, cell line development is required. FACS experience is desirable but not required.
- This position requires capture of every detail of bioassay development in the form of electronic notebook. Should be able generate the SOPs, technical reports, and bioassay assay trending.
- Prior experience or technical knowledge in molecular assays such as qPCR, ddPCR and NGS would be good to have but not essential for this position.
If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.