Principal Scientist, CMC Documentation & Stability
- New Brunswick, NJ
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Senior Research Scientist/Senior Research Investigator
This position is in the Stability group of the Analytical and Bioanalytical Development and is located at the BMS facility in New Brunswick, New Jersey
• BS/MS/PhD in chemistry, pharmacy/pharmaceutical sciences, biochemistry, or related field of science.
• 6 or more years of experience in the pharmaceutical industry, with experience in designing and writing stability protocols for small- or large-molecule, investigational or registrational, studies, and in analyzing large sets of data.
• Demonstrated experience in authoring stability sections of CTA's and registrational filings.
• Ability to apply understanding and knowledge of pharmaceutics, pharmaceutical development and global stability guidelines to the development of stability protocols and the analysis of stability data.
• Demonstrated understanding and application of ICH guidelines as they relate to stability and ability to design complex stability protocols to support the intended purpose.
• Strong technical-written and verbal communication skills.
• Ability to prioritize and manage multiple large projects simultaneously and complete deliverables within established timelines.
• Proficiency in working in Word, Excel and LIMS systems.
• Understanding and knowledge of documentation practices required for a cGMP regulated environment.
• Strong familiarity with laboratory test methods desired.
• Ability to work independently in a complex, fast-paced, deadline driven environment
- Effectively and independently designs and authors stability protocols based on knowledge of global stability guidelines to support clinical use and registration of biologics drug substances and products.
- Analyzes and trends stability data. Independently identifies issues and works with development team to resolve them. Clearly and effectively summarizes and presents results from stability studies and authors technical memos and reports.
- Contributes to scientific and technical discussions with team members and external collaborators to resolve issues and communicate conclusions from stability studies.
- Authors the stability section in investigational and registrational global filings. Develops strategy and authors responses to stability-related questions from health authorities within the established timelines.
- Proposes label storage statement and shelf life for drug substance and drug product.
- Manages protocol and stability data reports in LIMS.
- Serves as the stability subject matter expert in development teams through global registrations.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
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