Scientist I, BioChemical Analysis
Catalent
Summary
The Scientist I is primarily responsible for method evaluation, optimization, transfer and validation activities under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. Also responsible for drafting technical documents such as methods, method forms, validation protocols and reports.
Job description
Position Summary
The Scientist I is primarily responsible for method evaluation, optimization, transfer and validation activities under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. Also responsible for drafting technical documents such as methods, method forms, validation protocols and reports.
The role
- Perform method evaluation, optimization, transfer, and validation activities under cGMP guidance
- Execute analytical testing for biologics using techniques such as HPLC/UPLC, electrophoresis, spectroscopy, and compendial assays
- Draft and review technical documents including methods, validation protocols, and reports
- Perform ad hoc sample testing and support method lifecycle activities
- Follow standard operating procedures with strong attention to detail
- Ensure accurate, legible, and compliant documentation in accordance with cGMP requirements
- Perform peer review of laboratory notebooks, logbooks, and technical documentation
- Train and coach peers on methods, instrumentation, and laboratory practices
The candidate
- Bachelor's Degree in Life Sciences or Physical Science with 6+ years of relevant experience, OR
- Master's degree with 4+ years of relevant experience, OR
- Doctorate degree in Life Sciences or Physical Science
- Applied knowledge of scientific principles in Biology, Chemistry, or Biochemistry
- Experience with analytical techniques (HPLC/UPLC, CE, spectroscopy, etc.)
- Experience working in a cGMP-regulated environment
- Experience with method development, transfer, validation, or optimization
- Experience drafting/reviewing technical documents (methods, protocols, reports)
Requirements
- Bachelor's Degree in Life Sciences or Physical Science with 6+ years of relevant experience, OR Master's degree with 4+ years of relevant experience, OR Doctorate degree in Life Sciences or Physical Science
- Applied knowledge of scientific principles in Biology, Chemistry, or Biochemistry
- Experience with analytical techniques (HPLC/UPLC, CE, spectroscopy, etc.)
- Experience working in a cGMP-regulated environment
- Experience with method development, transfer, validation, or optimization
- Experience drafting/reviewing technical documents (methods, protocols, reports)
Benefits
- Medical benefits
- 401K
- 152 hours PTO
- 8 Paid Holidays
Company overview
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) that serves as a trusted partner to pharmaceutical, biotech, and consumer health companies worldwide. Founded on a legacy dating back to 1933, Catalent has evolved into a comprehensive drug development and delivery leader with over 40 global sites. The company specializes in providing end-to-end solutions spanning oral dose formulations, biologics, specialty products, and clinical supply services. Catalent's expertise includes formulation development, analytical services, commercial manufacturing, and advanced delivery technologies such as Zydis® fast-dissolve tablets and softgel technologies. With over 1,000 active development programs at any given time, the company launches more than 100 new products and line extensions annually and has supported half of all FDA approvals over the past decade. Catalent produces over 60 billion treatment doses per year, helping approximately 200 million patients annually. Headquartered in Tampa, Florida, the company employs more than 10,000 professionals globally who are dedicated to putting patients first and championing the missions that matter in healthcare innovation.