Senior Biologist

Mallinckrodt Pharmaceuticals•Saint Louis, MO

1d•Hybrid

About The Position

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.

Requirements

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 development of cell-based potency assays is strongly preferred.
Extensive hands-on experience with protein characterization techniques, including Western blotting, ELISA, and automated capillary immunoassay platforms such as ProteinSimple Jess or Peggy Sue.
Experience with molecular biology methods including PCR, qPCR, RT-qPCR, and gene expression analysis.
Experience supporting product investigations, process understanding, and manufacturing-related technical studies is highly desirable.
Knowledge of GMP regulations, assay validation principles, and regulatory expectations for biological products.
Experience with LC-MS, proteomics, and advanced protein characterization techniques is desirable.
Strong scientific and technical expertise in cell and molecular biology.
Demonstrated leadership and CRO management capabilities.
Excellent analytical thinking and problem-solving skills.
Strong written and verbal communication skills.
Ability to work independently while effectively collaborating within cross-functional teams.
Strong organizational skills and attention to detail.
Proficiency with Microsoft Office applications and scientific data analysis software.
Ability to communicate effectively with technical teams, leadership, and external collaborators.

Nice To Haves

Working knowledge of FDA, ICH, and USP requirements applicable to biological assays and product characterization.

Responsibilities

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.
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.