Analytical Team Leader (Biologics)
About the Job
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.
The Analytical Team Leader (Biologics) manages CMC analytical development of multiple biologics pipeline candidates and provides leadership to a matrix team of analytical scientists from several disciplines such as analytical methods, impurity assays, characterization, biological assays, and GMP operations. The ATL also represents the entire analytical function in the integrated project team(s) and partners with representatives from key functions such as process, manufacturing, quality, formulation, and regulatory. The ATL coordinates all analytical activities, develops analytical strategy in partnership with the analytical functional heads, establishes timeline, and manages matrix teams to support overall CMC development. The ATL manages programs spanning from preclinical development through late stage clinical development and registration.
The position provides exciting opportunity to be involved in early/late stage clinical development programs, progress the assets to marketing approval, and bring life-saving medicines to patients who are waiting. It also offers possibility of getting involved in diverse modalities including antibody, fusion protein, oligos, and fixed dose combinations. The ATL role is highly visible to senior leadership, and provides unique pathway for career development and growth.
The ATL will be accountable for managing delivery and timeline of analytical development activities at multiple sites including New Jersey sites, and partners with functional heads who own these development activities. This includes method development/validation, structural/functional characterization, release testing, comparability, stability testing, regulatory filing, and related activities. Limited business travel to other sites may be required.
PhD (or MS) in analytical sciences, biochemistry, pharmaceutical sciences, biology, or related disciplines, and 6+ years (or 10+ for MS) of experience in biologics CMC development
- Proven leader with experience in managing matrix technical teams, and experience in resolving technical issues
- Strong interpersonal and communication skills
- Desired\: Knowledge of analytical and biochemical techniques, chromatography, immunoassays, biological function, protein structure, and biologics characterization
- Desired\: Experience in partnering with CDMO for method transfer, GxP testing, and co-validation
- Desired\: Knowledge of biologics CMC development from pre-clinical through clinical to commercialization