Lead Scientist, Molecular & Cellular Biology
About The Position
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.
Requirements
- 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
Responsibilities
- 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
Benefits
- Competitive medical benefits
- 401K
- 152 hours PTO
- 8 Paid Holidays
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
