Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.
Bristol-Myers Squibb is a global BioPharma company firmly focused on its Mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. BMS delivered 14 new medicines to patients in the past 10 years. Innovation is critical for successfully executing our BioPharma strategy.
Bristol-Myers Squibb's pipeline is one of the most innovative in the industry. Our pipeline includes a number of biologics products such as YERVOY®, ORENCIA®, NULOJIX®, and a number of exciting clinical stage compounds including anti-PD1 mAb. We embrace a diverse workforce and inclusive culture. The health, safety, professional development, work-life balance and equitable, respectful treatment of our employees are among our highest priorities.
The Group Leader position is accountable for leading the Impurities group that supports a portfolio of early and late stage clinical and commercial programs. This position reports to the Director of Analytical Method Development department, within the Biologics Development organization of BMS’ Global Manufacturing and Supply (GMS) division.
Responsibilities: Directly accountable for the development, qualification, transfer and validation of analytical immunochemical assays focused on process related impurity assays for early and late stage development programs, direct supervision of scientific staff, and strong collaboration with customer groups.
Specific activities include:
•Develop, qualify and validate immunochemical methods for process related impurities including host cell protein, host cell DNA, cell culture and downstream processing residues for clinical and commercial programs.
•Drive analytical strategy decisions for developing methods for in process controls, and drug substance release.
•Provide oversight for the qualification, validation, verification and transfer of impurities methods.
•Lead troubleshooting activities and strategic plans for impurity methods.
•Evaluate and make recommendations on new instrumentation and technology used in impurities methods.
•Initiate, as needed, systems and practices to support proper documentation, review, traceability and archival of data.
•Work with process groups to define impurity method strategies for new molecules.
•Prepare and/or review documents in support of CMC regulatory filings.
•MS or PhD in biochemistry, immunology or equivalent field.
•12+ years extensive immunoassay experience in Biologics development.
•Strong knowledge of immunoassays and gels, Western blots and process-related impurity assays
•Proven leader who has managed a group of scientists.
•Strong interpersonal and communication skills.
•Demonstrated track record working in a regulated environment (cGMP and GLP) in Biotechnology
•Must have a clear understanding of global regulatory filing requirements.
•Experience interacting directly with CROs and Health Authorities (FDA, EMEA etc) is desirable.
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