We are seeking a motivated Scientist to join our Analytical Research and Development team and lead method development and qualification for lot release and characterization of cell and gene therapy products and critical materials. S/he will work with a Beam’s Analytical Development team to enable the rapid advancement of cell and gene therapy candidates from pre-clinical development through commercialization. The ideal candidate will be independent and detail oriented, have experience in design and development of novel functional cell-based and molecular assays, work collaboratively with cross-functional teams, and have a working knowledge of analytical guidelines and methods.
- Lead development, optimization, and qualification of cell and molecular assays used for lot release and characterization of cell and gene therapy products and critical materials.
- Independently design and perform cell-based and molecular assays including potency assays.
- Identify assay improvement opportunities, and design and execute comparability studies to support assay improvements and process improvements over the lifecycle of the product.
- Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions.
- Contribute to technical transfer of analytical methods both internally and to external vendors.
- Work with cross-functional groups including Research & Development, QC, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigation.
- Analyze, track, and trend data to monitor analytical assays, ensure consistency in assay performance, and identify assay improvements throughout the assay life cycle.
- PhD in Immunology, Biological Science, Biochemical Engineering, or related discipline with 0-2 years of R&D / analytical development experience or Bachelor’s or Master’s degree with 10 years of relevant experience.
- Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, ELISA, and IF/ICC.
- Experience with MoA, functional, or potency assay development is a preferred.
- Excellent organizational skills and ability to multi-task in a fast-paced environment.
- Team player with excellent oral and written communication skills.
- Ability to critically think though experimental challenges and troubleshoot.
- Knowledge of ICH/USP guidelines and experience with assay qualification/validation preferred.