Senior Biologist

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.
• 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.

Qualifications

Education: 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.

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.

Competencies

• 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.