Senior Scientist, Biologics Analytical Methods

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 Senior Scientist, Biologics Analytical Methods is responsible for contributing to analytical control strategy of major quality attributes in portfolio programs. The Senior Scientist will strategize and plan for developing robust analytical methods of biologic programs in early and late stage clinical development. This position directly reports to the Group Leader, Biologics Analytical Methods.
Bristol-Myers Squibb is the industry leader in immuno-oncology and other innovative therapies with life-saving medicines such as Opdivo?, Yervoy?, Empliciti?, Eliquis?, and a rich clinical portfolio of diverse modalities including monoclonal antibody, fusion protein, gene therapy, and combination regimes. The candidate will have opportunity to work on a variety of biologic compounds across various therapeutic modalities, and actively partner with various biologics development & commercialization groups across sites in New Jersey, New York, Massachusetts, and globally.
Directly responsible for:
Establishing innovative and robust analytical methods for major quality attributes such as protein aggregates, protein clips, charge variants, chemical modifications such as deamidation, oxidation, and other product-related substances/impurities;
Development, validation, and transfer of chromatographic, electrophoretic, and mass spectrometric (MS) methods targeted for in-process, release and stability for early and late stage biologics development programs;
Contributes to assessing method performance - both scientific as well as robustness;
Matrix team leadership of in-function and cross-function technology initiatives as well as analytical project teams.
Actively collaborates with partner groups;
Strong focus on advancing our capabilities in attribute sciences including new technology development;
Prepare and review documents in support of CMC regulatory filings
Key Competencies:
Ph.D. in analytical chemistry, biotechnology, pharmaceutical sciences, biochemistry, or equivalent field, with a minimum of 5 years (or MS with minimum 10 yrs) of relevant experience in biotech/biopharma.
Experience in biologics development including analytical sciences and protein sciences
Hands-on experience in applying chromatographic, electrophoretic, and MS techniques to therapeutic proteins, such as SEC, RP-LC, IEX, HIC, CGE (CE-SDS), iCIEF, HILIC, 2D-LC, LC-MS (QTOF) etc.
Proven technical leader with direct experience in analytical method development/validation, and forced degradation
Strong interpersonal and communication skills.
Desired: Understanding of global regulatory filing (e.g. FDA, EMEA etc) requirements for biologics.
Desired: Experience interacting directly with CROs.

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