Scientist II, Analytical Chemistry
On-siteLexington, Kentucky, United States
Job Summary
Develop, optimize, validate, and transfer analytical methods for components, excipients, drug substances, and drug products across pharmaceutical development stages. Perform routine and non-routine testing of raw materials, in-process samples, and finished products to support formulation and process development. Generate, interpret, and communicate analytical data to support regulatory submissions and technical decision-making while maintaining cGMP, GLP, and company quality standards. Collaborate with cross-functional teams to troubleshoot technical challenges, qualify new laboratory equipment, and contribute to CMC documentation for IND, NDA, and ANDA submissions. Drive continuous improvement initiatives to enhance laboratory efficiency and implement solutions to complex technical problems.
Required Qualifications
- Degree in a scientific field: PhD or MS with 0+ years of experience; or BS with 3+ years of experience; or 7+ years of experience without a Bachelor's degree
- Strong attention to detail and scientific rigor
- Ability to work both independently and collaboratively in a fast-paced environment
- Proficiency in analytical instrumentation and techniques including HPLC, GC, UV-Vis, FTIR, Karl Fischer, spray testing, and related analytical techniques
- Familiarity with cGMP, ICH, and FDA guidelines
- Competency in analytical data interpretation, documentation, and scientific reasoning
- Strong organizational, written, and verbal communication skills
- Ability to work independently and manage time efficiently
Desired Qualifications
- Experience in an FDA-regulated environment
- Experience with nasal spray drug products and devices
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