Scientist I, BioChemical Analysis
About The Position
Catalent’s Kansas City facility is a leading center for integrated development, manufacturing, and packaging services for oral solid dosage forms. The site combines advanced technologies with a collaborative environment to support pharmaceutical development from early-stage formulation through commercial supply. With a strong focus on quality and innovation, the campus offers modern laboratories, state-of-the-art manufacturing suites, and specialized capabilities to meet diverse client needs. This location fosters teamwork and continuous learning, making it an excellent setting for professionals who want to contribute to delivering life-changing therapies while working in a dynamic and supportive environment. 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.
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)
Responsibilities
- 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
Benefits
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
