Biologics Method Development & Validation Scientist I

Catalent; Kansas City (MO); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive medical benefits and 401K

152 hours PTO + 8 Paid Holidays

Dynamic, fast-paced work environment

Continuous Improvement Processes

Job summary

Catalent's Kansas City facility is a leading center for integrated development, manufacturing, and packaging of oral solids. The Scientist I executes method evaluation, transfer, and validation under cGMP, performing analytical testing with HPLC/UPLC, electrophoresis, spectroscopy, and compendial assays.

The role requires a Bachelor's with 6+ years, or a Master's with 4+ years, or a PhD in Life or Physical Sciences, plus experience drafting methods and reports and training peers.

Qualifications

• Bachelor's, Master's, or Doctorate with relevant experience in biologics/chemistry.
• Experience in cGMP regulated environments and method development.
• Drafting protocols, methods, and validation reports with attention to detail.

Responsibilities

• Perform method evaluation, transfer, and validation under cGMP guidance.
• Execute analytical testing for biologics using HPLC/UPLC, CE, spectroscopy.
• Draft and review methods, validation protocols, and technical reports.
• Train peers on methods, instrumentation, and laboratory practices.
• Maintain compliant documentation and perform peer-review of notebooks.

Skills

Applied knowledge

cGMP experience

Analytical methods

Education

Bachelor's Degree in Life Sciences or Physical Science

Master's degree in Life Sciences or Physical Science

Doctorate in Life Sciences or Physical Science

Tools

HPLC/UPLC

CE

Spectroscopy

Job description

Catalent's Kansas City facility is a leading center for integrated development, manufacturing, and packaging of oral solids. The Scientist I executes method evaluation, transfer, and validation under cGMP, performing analytical testing with HPLC/UPLC, electrophoresis, spectroscopy, and compendial assays.

The role requires a Bachelor's with 6+ years, or a Master's with 4+ years, or a PhD in Life or Physical Sciences, plus experience drafting methods and reports and training peers.