Analytical Development Lead:
The Analytical Lead will design, plan, oversee and coordinate analytical activities for our Hematology cell therapy platform as well as future delivery platforms. This role will focus on CMC related analytical activities beginning at pre-clinical and preceding through commercial launch. This role will oversee internal and external activities including, but not limited to, method development, method transfer, phase appropriate method qualification/validation, non-GMP testing, non-GMP stability, reference standard qualification, and comparability. Candidate should have expertise in various techniques, such as flow cytometry, NGS, qPCR, ddPCR, DNA and RNA extraction, ELISA, western blotting, transfections, electroporation, and cell-based potency.
- Establish Analytical CMC Strategy for Hematology cell therapy programs.
- Work on cross-functional CMC team progressing candidates from pre-clinical through commercial launch.
- Authors and coordinates writing of test methods and ensure timely transfer of test methods to CDMOs, CTOs, and Quality.
- Coordinates writing of and authoring of method qualification reports and reference standard qualification protocols and reports.
- Define analytical control strategy for Hematology cell therapy programs.
- Establish product characterization studies.
- Creation of justification of specifications and specifications documents.
- Authors all relevant sections of IND and BLAs as well as respond to regulatory agency questions.
- Interface with CMC, Quality, Regulatory, Manufacturing, Process Development, and Beam partners.
- Degree (MS, PhD) in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related fields).
- Minimum 15 years (MS) or 10 years (PhD) industry experience (including biotech, biopharma, CRO, CDMO) including hands on experience in cell and gene therapy.
- Analytical development expertise in protein biotherapeutics, RNA/Oligos, and/or cell therapy products.
- Knowledge and experience in CMC and regulatory strategy, cGMP, ICH guidelines, USP and EP compendial methods applied to cell and gene therapy is preferred.
- Candidate should have expertise in various techniques, such as flow cytometry, NGS, qPCR, ddPCR, DNA and RNA extraction, ELISA, western blotting, transfections, electroporation, and cell-based potency.
- Extensive scientific writing experience, experience authoring IND and related documentation.
- Strong leadership, self-starter and excellent oral and written communication skills.