Principal Scientist
3 weeks ago
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that improve patients' lives. We are seeking a highly skilled and experienced Principal Scientist to join our team in New Brunswick, New Jersey.
Job SummaryThe Principal Scientist will act as a technology transfer lead in the parenteral manufacturing MS&T group, ensuring the technical interface between sending and receiving sites. This position is accountable for designing and transferring robust manufacturing processes for new products and key lifecycle parenteral products. The successful candidate will be responsible for ensuring processes are designed and validated per applicable cGMPs, BMS procedures, and regulatory filings.
Key Responsibilities- Lead parenteral technology transfer projects for key lifecycle biologic parenteral products, including process/parameter establishment and completion of process performance qualification and subsequent CMC filing activities.
- Develop, characterize, optimize, and troubleshoot product and manufacturing processes of parenteral dosage forms.
- Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
- Design, prepare, and review technology transfer protocols, methods/processes, experimental, and/or authoring plans and/or templates as appropriate.
- Partner with site management teams to identify best practices in industry-related technology transfers, pharmaceutical technology, and create a competitive advantage.
- Representative on global supply strategy groups/site forums and to relevant stakeholders across the company.
- Lead, motivate, mentor, and develop team members to meet and exceed plant and company goals and objectives.
- Develop and maintain effective working relationships with other division groups in support of technology transfer, validation, and process support activities.
- Responsible for reviewing and co-authoring key CMC sections.
- Bachelor's degree in Pharmacy, Biochemistry, Chemical Engineering, or related Pharmaceutical sciences.
- Seven (7) years of directly related experience in Technical Services work within the pharmaceutical industry.
- Three (3) years of experience in parenteral manufacturing of protein therapeutics (biologics) strongly preferred, along with demonstrated knowledge of how these products behave in parenteral processes.
Bristol Myers Squibb offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment that fosters innovation, collaboration, and excellence.
Join us in our mission to transform patients' lives through science.
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