The successful candidate will develop and evaluate the performance of cellular and biochemical potency assays to support advancement of various company platforms.
- Develop in vitro potency assays (e.g. cell-based, ELISA/MSD, FACS, functional activity) and cytokine-based immunoassays using cultured and primary mammalian cells to support product development.
- Standard mammalian cell culture support including maintaining and plating of cell lines.
- Transfer of potency assays to CRO/QC laboratory for qualification and validation and for release and stability testing under GMP conditions.
- Data analysis, writing method protocols, study reports, and SOPs.
- Presentation of data to project teams.
- Master’s/Bachelor’s degree in Biology, Biotechnology, Bioengineering, Immunology, or a related subject.
- 3-6 years of experience in a pharmaceutical organization or a CRO/CMO.
- Open to learning new techniques as required.
- Independent thinker and team player.
- Required: Expertise with cell culture, developing cell-based potency assays, and standard immunological methods such as ELISA/MSD and western blotting.
- Preferred: Experience developing potency assays in a quality environment; experience developing multiplex cytokine assays (e.g. MSD, ELLA); experience with viral infectivity assays; familiarity with ICH guidelines for assuring quality of drug substance or drug product.