The Associate Scientist will execute in-process analytical testing, assay development, and GMP testing when needed for gene therapy products, collaborating with a multidisciplinary Process Development Team, GMP testing team, Quality Assurance, and Manufacturing team.
Primary Responsibilities:
- Execute testing in the development laboratory.
- Collaborate with a diverse team to execute assays for gene therapy applications.
- Conduct cell-based, molecular, and analytical assays.
- Design, execute, and interpret experiments under supervision to meet objectives.
- Write test methods in accordance with company objectives for SOPs and GMP test methods.
- Conduct development, verification, and qualification studies on various test methods as well as routine sample testing.
- Develop presentations and communicate technical results to internal technical groups.
- Maintain accurate laboratory records and draft technical reports to comply with good laboratory practices and SOPs.
- Generate, analyze, and record high-quality data using documentation and database tools.
- Contribute to laboratory organization, maintenance, and stocking of pertinent assay materials.
- Independently execute analytical methods to characterize viral vector products.
- Perform analytical testing in support of process development, cGMP investigations, and product characterization.
- Characterize process- and product-related impurities in cell products and viral vectors in collaboration with process development teams.
Education, Experience, & Qualification:
- Bachelor’s or Master’s degree in Biology, Biochemistry, Molecular Biology, Immunology, or related discipline.
- 1–4 years experience in cell and molecular biology, biochemistry, chemical engineering, or related field with relevant lab experience in pharma/biotech.
- Experience with in-process analytics and characterization methods including plate-based assays, immunoassays/ELISAs, PCR-based assays (qPCR, ddPCR, dPCR), or other common analytics is strongly preferred.
- Experience in mammalian cell culture, cell-based assays, and aseptic techniques strongly preferred.
