LeadScientist,Molecular&CellularBiology

Lead Scientist, Molecular & Cellular Biology **Position Summary** * Shift: Monday-Friday 8am-5pm * 100% on-site Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. 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 instrumenta