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Group Leader - 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 Group Leader, Biologics Analytical Methods is accountable for establishing analytical control strategy of major quality attributes by developing robust analytical methods for biotherapeutic drug candidates in the portfolio of Bristol-Myers Squibb spanning early and late stage clinical programs. This position directly reports to the Head of Methods & Analytical Development within Biologics Development organization.
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.
Responsibilities:
Directly accountable for:
Assessing and establishing analytical control strategy for major quality attributes such as protein aggregates, fragments, charge variants, chemical modifications, 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;
Understanding performance of the methods - both scientific as well as robustness;
Direct supervision of scientific staff, and maintaining/initiating strong collaboration with partner groups;
Strong focus on advancing our capabilities in attribute sciences including new technology development;
Prepare and/or review documents in support of CMC regulatory filings and addressing queries from health authorities
Key Competencies:
Ph.D. in analytical sciences, biotechnology, pharmaceutical sciences, biochemistry, or equivalent field, with a minimum of 8 years (or MS with minimum 13 yrs) of relevant experience in biotech/biopharma.
Experience in biologics development including analytical sciences and protein sciences
People management experience; strong interpersonal and communication skills.
Deep knowledge and experience in applying chromatographic, electrophoretic, and MS methods to therapeutic proteins. Such as SE-HPLC/UPLC, RP-LC, IEX, HIC, CGE/CE-SDS, iCIEF, HILIC, 2D-LC, LC-MS etc.
Proven technical leader with direct experience in analytical method development, validation, and forced degradation
Must have a clear understanding of global regulatory filing requirements for biologics.
Desired: Experience interacting directly with CROs and Health Authorities (FDA, EMEA etc).
Desired: Experience in biologics process development, characterization, CQA assessment, and multi-attribute techniques.



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