Lead Scientist, Molecular & Cellular Biology

Position Summary Shift: Monday-Friday 8am-5pm 100% on-site The Lead Scientist I is primarily responsible for assay generation, design, development, and validation efforts for Biopharma product development under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. Also responsible for drafting, reviewing, and approving technical documents such as SOPs, methods, method forms, validation protocols and reports. The role Lead assay generation, design, development, and validation efforts for Biopharma product development under cGMP regulatory guidance for Large Molecules/Biologics Execute laboratory testing using techniques such as mammalian cell culture, cell-based assays, ELISA, molecular biology, flow cytometry, and binding assays (SPR/BLI) Draft, review, and approve technical documents including SOPs, methods, validation protocols, and reports Serve as a subject matter expert (SME) across multiple techniques and perform sample testing activities Mentor, coach, and train peers on cGMP compliance, methods, and laboratory instrumentation Ensure accurate, thorough, and compliant documentation in accordance with cGMP requirements Lead and coordinate peer review of laboratory documentation including notebooks, reports, and protocols Support project execution through assay development, scope design for proposals, and tracking changes throughout the project lifecycle The candidate Bachelor’s Degree in Life Sciences or Physical Science field with minimum of 11 years relevant experience in department specific techniques, OR Master’s degree in related life science or physical science field with a minimum of 9 years relevant experience in department specific techniques, OR Doctorate degree in related life science or physical science field with a minimum of 5 years relevant experience in department specific techniques Applies advanced knowledge of principles, theories, and concepts in disciplines such as Biology, Chemistry, or Biochemistry In-depth knowledge of instrumentation, theory, data interpretation, and applications in at least one technical area Why you should join Catalent Competitive medical benefits and 401K 152 hours PTO + 8 Paid Holidays Dynamic, fast-paced work environment Opportunity to work on Continuous Improvement Processes Catalent is an Equal Opportunity Employer, including disability and veterans. #J-18808-Ljbffr Catalent