Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Scientist / Senior Scientist level. The ideal candidate will be familiar with a broad range of analytical chemistry techniques, possess a strong work ethic and strong technical background, demonstrate excellent oral and written communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail. Responsibilities Develop and validate analytical methods for starting materials and peptides. Characterize new reference standards by a variety of analytical techniques. Conduct routine and non‑routine analysis of raw and starting material samples. Document and compile data for quality review. Review data for compliance to specifications. Conduct analytical investigations. Author scientific reports and portions of the CMC section of regulatory filings. Author SOPs as needed (e.g., analytical methods, equipment procedures, and material specifications). Present at internal and cross‑functional scientific meetings. Qualifications Ph.D. in analytical chemistry or related discipline with at least 2 years of industry experience. Skilled in developing methods using LC-MS, HPLC, and GC. Good understanding of the drug development process. Practical knowledge of GMP requirements, with hands‑on GMP experience preferred. Familiarity with ICH and FDA method validation guidelines, including phase‑appropriate strategies. Ability to problem‑solve, manage priorities and maintain aggressive timelines for multiple projects. Ability to work productively and independently within a team or matrix environment. Excellent written and verbal communication skills. #J-18808-Ljbffr
Scientist / Sr. Scientist • Carlsbad, CA, United States
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