Senior Biologist

Senior Biologist

JR Senior Biologist (Open)

St. Louis, MO

Hazelwood, MO

Keenova Therapeutics is seeking a highly motivated and experienced Senior Biologist to join the Global Technical Operations team. This role will provide scientific leadership in the development, validation, transfer, and application of biological assays to support the characterization, quality control, and lifecycle management of biotherapeutic products and manufacturing materials. Responsibilities include development of cell-based potency assays and protein and gene expression characterization methods.

The successful candidate will collaborate across functions to support assay modernization initiatives, product development, manufacturing investigations, and regulatory activities.

• Serve as a technical leader in cell and molecular biology, leading development, validation, and transfer of biological assays for biotherapeutic products.
• Design, develop, optimize, and validate cell-based potency assays, protein characterization methods, and molecular biology assays in accordance with current regulatory expectations.
• Apply expertise in protein and gene expression analysis, including mammalian cell culture, cell-based assays, PCR/qPCR, Western blotting, ELISA, flow cytometry, and related methodologies.
• Provide technical troubleshooting and scientific guidance to resolve complex analytical and biological challenges.
• Characterize proteins, peptides, raw materials, intermediates, drug substances, and drug products to support manufacturing, investigations, and product lifecycle management.
• Lead CROs and cross-functional teams to execute projects and achieve development objectives.
• Work with PM to establish project timelines, coordinate functional activities, and ensure delivery of milestones.
• Evaluate data, interpret results, and prepare technical reports suitable for internal stakeholders and regulatory submissions.
• Demonstrate excellent verbal and written communication skills. Responsible for clear communication in both written and oral forms to a broader audience.
• Collaborate effectively with Process Chemistry, Formulation, Analytical Development, Manufacturing, Quality, Operations, and Regulatory Affairs teams.
• Contribute to scientific innovation through implementation of new technologies, publications, intellectual property, and technical know-how.
• Ensure activities comply with applicable GMP requirements and regulatory guidelines.
• Maintain complete and accurate laboratory documentation and follow established safety practices.

• Working knowledge of FDA, ICH, and USP requirements applicable to biological assays and product characterization.
• Support preparation of technical summaries, reports, and documentation for regulatory submissions and health authority interactions.
• Contribute to development of regulatory strategies related to assay validation, comparability, and product characterization.

• Ph.D. in Biology, Molecular Biology, Cell Biology, Biochemistry, Biotechnology, or a related life science discipline.
• M.S. or B.S. in a related scientific discipline may be considered with appropriate industry experience.

• Ph.D. with 5+ years of relevant pharmaceutical or biotechnology industry experience.
• MS with 7+ years of relevant pharmaceutical or biotechnology industry experience.
• B.S. with 10+ years of pharmaceutical or biotechnology industry experience.

• Demonstrated expertise in development, qualification, validation, and transfer of cell-based potency assays and biological methods.
• Experience with mammalian cell culture, biotherapeutic product characterization, and…