Principal Scientist Stability Expert
4 weeks ago
Bristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Principal Scientist Stability to join our team.
About the RoleThe Principal Scientist Stability will be responsible for developing and implementing stability product strategies and overseeing product stability programs for commercial small molecules Drug Substances and Drug Products. This role will involve participating in transfer teams, reviewing registrational stability studies, and conducting gap analyses against Global Manufacturing & Supply requirements.
Key Responsibilities- Develop and maintain expertise on the overall stability performance of products manufactured in the global supply chain.
- Develop and implement stability data where gaps exist.
- Author and approve stability protocols, and prepare, review, and approve stability reports and regulatory filings.
- Participate in cross-functional projects and represent the department in health authority inspections.
- Ensure training requirements are met and act as an advisor and mentor to stability staff.
- Bachelor's degree in Chemistry, Biology, Microbiology, or a relevant discipline.
- 8 years of relevant work experience in a pharmaceutical environment.
- Expert knowledge of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives, and guidance documents.
- Thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
Bristol Myers Squibb offers a competitive benefits package, including a wide variety of services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. We are committed to creating a diverse and inclusive work environment that promotes collaboration, innovation, and excellence.
We are an equal opportunity employer and welcome applications from qualified candidates of all backgrounds. If you are a motivated and experienced professional looking for a challenging and rewarding role, please submit your application.
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