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 offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
