Beam is seeking an exceptionally talented Director/Sr. Director with deep expertise in biological assay development, qualification, and validation. The candidate will need to be a thought leader in analytical sciences and development with exceptional understanding of innovative technologies that enable development of robust assays. The suitable candidate will have a good understanding of key assays required for manufacture and release of plasmids, oligonucleotides, and lipid nanoparticles. Key experience in validating immunological, PCR, Flow, Potency and Cell Based Bioassays for Pivotal/Commercial use is necessary. The lead candidate should also have demonstrated leadership in a similar role at a Biotechnology or large Pharma company. The candidate will lead a team in charge of external and internal tech transfers of key assays and coordinate cGMP batch release internally and at CDMOs. The candidate will lead a group of scientists working on assay qualification/validation and lead CDMO evaluation, and engagement. The ideal candidate should have deep understanding of ICH guidelines, Quality by Design (QbD), and Critical Quality Attributes (CQA) assessment. Extensive understanding of cGMP regulations and developing risk-based analytical control strategies around Cell and Gene therapy products is necessary.
- Oversee a team of scientists and execute development, qualification, and validation of key assays.
- Provide technical oversight and guidance to analytical team.
- Work cross-functionally to advance functional and immunological assays for pivotal/commercial release with internal and external Quality units.
- Lead development of next gen assays for early and late-stage purposes.
- Analyze, interpret, and present data to internal and external audience using various formats.
- A thought leader in Analytical Sciences and Development.
- PhD degree with 10 to 14 years’ experience or MS degree with 15+ years analytical development experience in a Pharmaceutical or CDMO organization.
- Previous experience with assay qualifications and validation is necessary.
- Good understanding of cGMP manufacturing guidelines.
- Prior experience with tech transfer of assays.
- Knowledge of key analytical testing of mRNA and LNPs.
- Proven Leadership.
- Effective communication skills.
- Strong work ethic.