Principal Scientist, Biologics Method Excellence Lead
0545 Devens, New Brunswick New Jersey
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
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Position: Principal Scientist, Biologics Method Excellence Lead
Location: New Brunswick, New Jersey
Bristol-Myers Squibb is inviting applications for Principal Scientist, Biologics Method Excellence Lead in the Methods & Analytical Development organization. The Methods & Analytical Development organization is accountable for establishing analytical control strategy of major quality attributes including development of phase-appropriate analytical methods for biotherapeutic drug candidates in the portfolio of Bristol-Myers Squibb spanning early and late stage clinical programs through commercialization. This position directly reports to the Head of Methods & Analytical Development, and serves as a key member in the leadership team.
The Method Excellence Lead is responsible for developing technical strategy of method excellence and implementing the excellence paradigm to new and existing methods in clinical development. The scope includes operational excellence for our release and stability methods including continuous improvements as well as incorporating new technology in our development toolbox. The Lead provides guidance to matrix team scientists and partners with leaders responsible for method development and validation. The Method Excellence Lead will be an individual contributor or directly manage a small group of 1-2 scientists depending on need of this function. The Lead is expected to be well versed and experienced in biologics development and analytical sciences, and possess a diverse background in analytical chemistry, protein chemistry, attribute sciences, mass spectrometry, electrophoretic and chromatographic separations.
The Methods & Analytical Development group is located in a brand new facility at New Brunswick, NJ with modern laboratory setup equipped with state-of-the-art analytical instrumentations. The Method Excellence Lead will build strong collaboration with stakeholders including QC, QA, regulatory CMC, analytical, formulation, process, characterization, biological function, and portfolio management.
Bristol-Myers Squibb has a strong biologics portfolio for innovative therapies that includes approved biologic medicines such as Opdivo®, Yervoy®, Empliciti®, Orencia®, Nulojix®, Reblozyl® and a rich clinical portfolio of diverse modalities including bispecific, trispecific, antibody, fusion protein, and fixed dose 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.
- Develop technical strategy of method excellence.
- Achieve operational excellence for GMP methods including continuous improvements
- Incorporate new technology in method development/validation tool box.
- Maintain/initiate strong collaboration with partner groups.
- Actively contribute to establishing analytical control strategy for clinical programs
- Actively contribute to method development, validation and transfer chromatographic, electrophoretic, and mass spectrometric methods targeted for in-process, release and stability for early and late stage biologics development programs.
- Support CMC regulatory filings and addressing queries from health authorities.
• Ph.D. in analytical sciences, biotechnology, or related field, with a minimum of 7 years (or MS with minimum 12 yrs) of direct experience in CMC development in biotechnology.
• Experience and acumen in biologics analytical development.
• Demonstrated matrix leadership with solid communication skills and an ability to deliver results through teamwork.
• Ability to influence and build effective collaboration
• Deep knowledge in applying chromatographic, electrophoretic, mass spectrometric, and light scattering methods to therapeutic proteins. Such as SE-HPLC, SE-UPLC, RP, IEX, HIC, CGE, CZE, HILIC, 2D-LC, LC-MS.
• High learning agility with demonstrated critical thinking and problem solving skills.
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.