Job Information
Bristol-Myers Squibb Company Principal Scientist in Summit, New Jersey
Provide strategic leadership of analytical activities in support of drug product development and to provide matrix leadership of a team of analytical scientists. Represent the Drug Product Development department on cross-functional teams responsible for analytical-related Chemistry, Manufacturing and Controls strategy (CMC) development. Support small molecule drug product formulation and process development including analytical characterization of the process and finished product as a Drug Product Analytical Team Lead as well as an individual contributor. Provide input and support for drug product specifications and analytical control strategy. Support registrational filings as an author / reviewer and provide support for responses to drug product analytical-related Health Authority inquiries. Develop, optimize and verify / qualify drug product analytical methods (High / Ultra Performance Liquid Chromatography, Dissolution and Gas Chromatography), and provide guidance to the Quality Control lab during method validation and technology transfer. Conduct and assess developmental stability studies on drug product and drug product intermediates to inform formulation design and packaging selection. Review and discuss analytical results and conclusions both orally and in writing and prepare formal reports for analytical method development and drug product development studies. Provide oversight and technical support for junior scientists and coach and mentor others in the department. Requirements: Master’s degree (or foreign equivalent) in Chemistry, or a related field plus 6 years of experience, or in alternative, Bachelor’s degree (or foreign equivalent) in Chemistry, or a related field plus 8 years of experience or Ph.D degree (or foreign equivalent) in Chemistry, or a related field plus 3 years of experience. The skills, knowledge and/or experience need not be maintained over the full term of experience required. The experience must include the following: •Analytical Project Leadership•High / Ultra Performance Liquid Chromatography•Dissolution and Gas Chromatography•Drug product development in various oral formulation types (capsules, tablets, suspensions, solpengutions)•Analytical support for drug product formulation / process development•Chemistry, Manufacturing and Controls (CMC) authoring/review•method validation•International Conference on Harmonization (ICH), Food and Drug Administration (FDA), United States Pharmacopeia (USP), European Medicines Agency (EMA)