Orange County Metro Area, CA
Has practical breadth and depth of knowledge in a variety of analytical techniques applied to testing drug substance and pharmaceutical dosage forms. Participates in bench-level drug substance/product stability testing and release of test articles and generates and evaluates accurate and precise data using advanced, validated, analytical technologies. Provides analytical support for investigative studies and troubleshooting analytical issues. Interacts with contract laboratories for assigned projects to troubleshoot analytical issues and/or address lab incidents and investigations. 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. Able to critically assess and statistically evaluate stability data to establish specifications, drug product expiration dating and label storage claims. Represents department and participates on cross-functional drug development project teams and coordinates the efforts within department to ensure timely completion of all required tasks to meet project milestones.
Essential Skills and Abilities:
Expert 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. Knowledge and use of basic statistics (i.e., hypothesis testing, regression analysis, analysis of variance) is required. Has a working knowledge and understanding of global regulatory requirements and expectations for product registration. Strong verbal and written communication skills and strong organizational skills are required. Strong data evaluation and analytical skills, and proven technical writing skills are necessary, as well as proven time management and analytical chemistry skills.
Skilled use of chemical analysis principles, theories, techniques and concepts applied to a broad range of sample types and solving special problems related to drug substance/product stability is required. Must have a thorough working knowledge of a wide range of analytical methods (i.e. HPLC, GC, spectroscopy, etc.). A working knowledge of ICH and international stability requirements is desired. Strong technical writing and communication skills are required. Must be proficient using statistical programs for analytical data evaluation. Ability to critically review and evaluate analytical data and make conclusions/recommendations based on data is required. Experience with and an understanding of cGMPs is necessary. Experience working in a cGMP analytical laboratory is required. Experience with oversight of drug substance and drug product stability studies to support drug development and product registrations is desired
Education and Experience Requirements:
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 required.