We are seeking a motivated Scientist to join our Analytical Development team and lead method qualification and transfer of flow cytometric assays for lot release and characterization. As a flow cytometry SME, the individual will be responsible for performing assay improvements, qualifications, and tech transfer of assays to both external and internal GMP testing laboratory. S/he will also be crucial in supporting the advancement of Beam’s cell and gene therapy candidates from early phase to commercialization. The ideal candidate will be a flow cytometry expert, be independent, detail-oriented, have experience with assay qualification/validation, and have a working knowledge of ICH guidelines.
- Lead the development, optimization, and qualifications of flow cytometry assays used for lot release and characterization of cell and gene therapy products and critical materials.
- Independently design and perform assay qualification, and tech transfer to internal QC teams as well as external CTLs.
- 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.
- Work cross-functionally with R&D, QC, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigation.
- Tech transfer and train QC personnel to enable them in running assays for lot release.
- Analyze, track, and trend data to monitor analytical assays, ensure consistency in assay performance, and identify assay improvements throughout the assay life cycle.
- Record highly detailed documentation of experiments in an ELN system.
- PhD in Life Sciences, Immunology, Chemistry, or related discipline with 0-2 years of relevant experience, or Master’s degree with 4-6 years, or Bachelor’s with 10+ years of relevant experience.
- Strong background with designing and running multicolor flow cytometry assays.
- Experience working in cell and gene therapy CMC: authoring SOPs, method qualification and technology transfer is a plus.
- Broad knowledge of ICH/USP guidelines.
- Excellent organizational skills towards multi-tasking in an extremely fast-paced environment.
- Team player with excellent oral and written communication skills.
- Independently motivated, detail-oriented, and excellent problem-solving abilities.
- Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, ELISA, and IF/ICC is a plus.
- GMP and QC experience is a plus.
- Domestic and international travel may be required to external CTLs and other Beam sites.