Analytical Chemist (Contractor)
On-site · Newark, Delaware, United States
Job Summary
Analytical Chemist (Contractor) to assist the Analytical Director in leading and coordinating physical and chemical characterizations using HPLC/UPLC, GC, SEC, LS, PM, and method development/validation. Responsibilities include developing, qualifying, validating, troubleshooting, and transferring HPLC/UPLC methods for assay, potency, impurities, and stability-indicating applications; performing CMC analytical testing for APIs, polymers/excipients, linkers/payloads, and formulated drug products; supporting stability programs, CRO/CMO/CDMO activities, and regulatory submissions (IND/NDA); preparing protocols, reports, and data packages; maintaining and troubleshooting analytical instruments; collaborating with R&D, manufacturing, quality, regulatory, and operations; ensuring compliance with cGMP/GLP and good documentation practices; and contributing to continuous improvement of analytical procedures and systems. Qualifications emphasize strong hands-on experience with HPLC/UPLC, knowledge of ICH/FDA CMC expectations, and ability to work in a fast-paced small-company environment.
Required Qualifications
- Bachelor of Science degree or higher with minimum 6 years of laboratory experience or Master’s Degree with 4 years or Ph.D. with 2 years in Chemistry, Biology, or related science
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