Scientist I, BioChemical Analysis
About The Position
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. The role also involves drafting technical documents such as methods, method forms, validation protocols, and reports. The position is based at Catalent’s Kansas City facility, a center for integrated development, manufacturing, and packaging services for oral solid dosage forms. The site provides modern laboratories, manufacturing suites, and specialized capabilities in a collaborative environment focused on quality, innovation, teamwork, and continuous learning.
Requirements
- Bachelor’s degree in Life Sciences or Physical Science with 6 or more years of relevant experience, or a master’s degree with 4 or more years of relevant experience, or a doctorate degree in Life Sciences or Physical Science.
- Applied knowledge of scientific principles in Biology, Chemistry, or Biochemistry.
- Experience with analytical techniques such as HPLC/UPLC, CE, and spectroscopy.
- Experience working in a cGMP-regulated environment.
- Experience with method development, transfer, validation, or optimization.
- Experience drafting or reviewing technical documents such as methods, protocols, and 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
- 401K
- 152 hours of PTO
- 8 paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
