Scientist Stability

Bristol Myers Squibb seeks a Senior Scientist for Stability in Boudry, Switzerland. The role involves leading stability product strategy, overseeing commercial small molecule programs, and ensuring regulatory compliance.

The company is looking for a Senior Scientist to serve as the Stability Product Lead for assigned brands. This position is responsible for defining the stability product strategy and providing oversight for stability programs covering commercial small molecule Drug Substances and Drug Products.

Responsibilities

• Act as the primary stability representative on project teams, managing post-approval changes and designing or executing premarket stability programs.
• Lead transfer teams for new products, review registrational stability studies, and perform gap analyses against Global Manufacturing & Supply requirements.
• Develop stability data to address identified gaps and maintain expertise on the stability performance of products within the global supply chain.
• Conduct change control impact assessments, document stability assessments, and review or endorse change controls.
• Define technical requirements in the Master Stability Protocol and approve study-specific protocols or batch enrollment forms.
• Manage the annual commercial stability program for assigned products in coordination with sample management groups.
• Write stability sections for CTD dossiers, including post-approval filings, annual reports, product renewals, and Annual Product Stability Reviews.
• Serve as the stability representative for Out of Trend (OOT) and Out of Specification (OOS) investigations, Market Action Fact Finding, and other quality-related inquiries.
• Lead work activities related to Change Controls and Corrective and Preventive Actions (CAPAs).
• Ensure stability procedures align with site department and Bristol Myers Squibb group procedures.
• Participate in or lead Operational Excellence (OpEx) initiatives to streamline and standardize stability program management.
• Support internal and external health authority inspections.
• Independently represent the department in cross-functional projects.

Requirements

• Bachelor of Science degree in Chemistry, Biology, Microbiology, or a related field.
• Minimum of five years of relevant work experience, preferably within a pharmaceutical environment.
• Deep understanding of stability ICH Guidelines (Q1A, Q5C) along with associated policies, directives, and guidance documents.
• Comprehensive knowledge of cGMP regulations as outlined in 21 CFR and their specific application to stability programs in pharmaceutical manufacturing.
• Familiarity with US, EU, and Rest of World (ROW) requirements, corporate directives, and industry best practices.
• Understanding of Drug Substance and Drug Product manufacturing processes, plus a solid grasp of analytical and/or microbiology methods.
• Experience in authoring documents and critically reviewing investigations to interpret results and generate technical conclusions consistent with Quality management principles.
• Experience overseeing external service providers involved in stability studies.
• Prior experience participating in health authority inspections focused on stability programs.
• Advanced proficiency in both English and French.

What the company offers

• Access to a wide variety of competitive benefits, services, and programs.
• Opportunities to grow and thrive alongside high-achieving teams.

About the company

Bristol Myers Squibb operates with a mission to transform patients' lives through science. The organization fosters a supportive culture that encourages global participation in clinical trials and upholds shared values of passion, innovation, urgency, accountability, inclusion, and integrity.

• Mission-driven focus on transforming patients' lives through science.
• Values centered on passion, innovation, urgency, accountability, inclusion, and integrity.
• Supportive environment promoting global participation in clinical trials.