Lead Scientist, Molecular & Cellular Biology

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 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.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.