Chemist - Pharmaceutical Development
Orange County Metro Area, CA
- Ph.D. and 0-3 years related experience or M.S. degree and 5-6 years related experience or B.S. degree and 10 years related experience. Degree should be in Pharmaceutics, Analytical Chemistry, Pharmaceutical Chemistry or Organic Chemistry.
- A minimum 2 years of experience in the analysis of data and writing of technical protocols, reports, and submission level documents is requiredExpert hands-on knowledge of chromatographic theory and technology (stationary phases, detectors and data management) is required.
- Strong working knowledge of HPLC, GC, dissolution, LC-MS, GC-MS, UV/Vis, and FTIR analytical techniques used to determine the potency, purity, and in-vitro performance of drug substance or drug products is required. Proven ability to troubleshoot experimental problems and lead investigations to resolve analytical issues is required.
Summary: Provides technical training and coaching to staff members. Has a working knowledge and understanding of global regulatory requirements and expectations for product registration and ICH Stability Guidelines. Designs, directs and conducts stability studies for drug substance and drug product to satisfy global regulatory requirements. Independently authors well-written critical technical documentation in the form of technical memos, protocols and reports and appropriate portions of CMC sections of INDs, NDAs, MAAs for use in submissions to world-wide government agencies for final market approval.