Scientist I, BioChemical Analysis
Catalent Pharma Solutions
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
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
- 401(k)
- 152 hours PTO
- 8 Paid Holidays
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.