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.
Among our several NJ locations, our Hopewell and Bloomsbury sites are key components of the Biologics Network Strategy, with available Process Development and Analytical Development opportunities to support innovative Biologics under development.
The Analytical CMC Manager manages CMC analytical development of multiple biologics portfolio projects and provides scientific matrix leadership to a team of analytical scientists from several disciplines such as biologics characterization, biological function assays, GMP operations and method development. This individual also represents the entire analytical function in the integrated project team(s) and partners with representatives from key functions such as process development, formulation development, quality, regulatory, manufacturing and supply chain. He/She coordinates all analytical activities, develops analytical strategy, establishes timeline, and manages matrix teams to support overall CMC development. He/She manages programs spanning from preclinical development through late stage clinical development and registration.
Bristol-Myers Squibb is the industry leader in immuno-oncology with life-saving medicines such as Opdivo®, Yervoy®, and Empliciti® and a rich clinical portfolio of diverse modalities including monoclonal antibody, antibody drug conjugate, fusion protein, and combination regimes. The candidate will have opportunity to actively partner with various biologics development groups across sites within US.
The Analytical CMC Manager will be directly accountable for managing delivery and timeline of analytical development activities at multiple sites including New Jersey. This includes method development, structural and functional characterization, release testing, comparability, stability study, regulatory filing, and related activities. The Lead w ill work closely with senior leaders in biologics development groups, and engage SMEs to develop analytical strategy of the programs he/she is responsible for.
Key Competencies/Qualifications :
• PhD or MS in analytical science, biochemistry, pharmaceutical sciences, biology, or related discipline, plus at least 4 years of experience in Biologics CMC development
• Strong program management and project management skills and adept at working collaboratively with cross functional teams
• Proven leader with experience in managing matrix teams in a technical environment
• Strong interpersonal and communication skills and knowledge of analytical and biochemical techniques, chromatography, biological function and biologics characterization
• Experience in oversight of CMOs/CROs for biologics method development, characterization, technology transfer, and release
• Knowledge of biologics CMC development from pre-clinical through clinical to commercialization
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.