Full Job Description
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The Stability Scientist is responsible for providing stability support for small molecule, non-sterile drug products manufactured at North America (NA) Manufacturing Sites, including overseeing all activities related to stability, maintaining expertise on stability standards, drug product performance, and stability program administration.
1. Participates on transfer team for new products to the sites, reviews registrational stability studies and conducts gap analysis against Global Product Development & Supply (GPS) requirements. Develops stability data where gaps exist.
2. Develops and maintains expertise on the overall stability performance of products manufactured at NA sites, including maintaining a working knowledge of the attributes that impact the products' performance/stability profile.
3. Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change.
4. Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.
5. Reviews and defines stability requirements on change proposals and completes all stability related tasks as assigned by the process.
6. Authors stability sections of CTD dossiers for post-approval filings, annual reports, and renewals and authors stability related responses to health authority inquiries.
7. Authors Annual Product Stability Reviews for inclusion in site issued Annual Product Quality Reviews in conjunction with Quality Operations.
8. Reviews and approves packaging bill of specifications (BOS) documents for new presentations or changes to primary packaging components.
9. Develops and maintains the master stability protocol for assigned drug products.
10. Provides all appropriate and necessary information to the contract laboratory in accordance with cGMPs, product registrations, applicable laws and regulations and BMS requirements.
11. Acts as a liaison between the contract laboratory and the BMS testing laboratory to resolve any issues relating to the analysis of stability samples.
12. Identifies batches meeting defined requirements for the marketed product stability program and other commitments for placement into the stability program.
1. Provides stability information and support during internal, external and regulatory inspections.
2. Executes work in compliance with cGMPs, BMS policies and directives, and site and departmental SOPs
3. Immediately reports OOS/OOT/deviations that have the potential to compromise product quality.
1. Maintains a safe work environment and follows site EHS policies and procedures.
2. Maintains awareness of safety and emergency procedures as they apply to the work area.
3. Utilizes Personal Protective Equipment (PPE) as necessary.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
1. Bachelor's degree or equivalent experience required; preferably in chemistry, microbiology, pharmacy, or other related science discipline. Master's degree highly desirable.
2. Strong understanding of cGMPs and regulatory requirements as they relate to laboratory practices and manufacturing processes.
3. Understanding of regulatory standards regarding stability.
4. Understanding of technical areas related to pharmaceutical manufacturing/packaging/distribution, chemical and microbiological analyses, statistical methods, and quality control and quality assurance.
5. Excellent verbal, written, and interpersonal communication skills are essential.
6. Demonstrated ability to plan, organize, and implement, complex projects.
7. Demonstrated ability to work with and manage people in a complex, changing environment to deliver value added results to the organization.
8. Ability to work with a wide range of technically and culturally diverse people.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.