Senior Principal Scientist, Upstream Process Development

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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Location

New Brunswick, NJ

Our Biologics Development team is responsible for development and transfer of safe, efficient, and approvable biologics drug substance manufacturing processes and analytical methods for all of BMS’ biologics portfolio. We work closely with other BMS units to support our clinical pipeline through to late stages of clinical development. Innovation is at the core of what we do, with an intense focus on efficiency, speed, robustness, and approvability of our processes and methods. Here, you’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, pursue innovative ideas, and advance professionally alongside some of the brightest minds in Biopharma.

The Biologics Development group at Bristol Myers Squibb in New Brunswick, New Jersey is recruiting for a Scientist Principal Scientist position in the Upstream Process Development team. This Senior Principal Scientist will work with teams across cell line development, upstream/downstream process development, and analytical groups to develop efficient and robust upstream processes for BMS’s biologics pipeline. Responsibilities include leading a team supporting upstream process development projects, overseeing clone selection, platform fit, process optimization, characterization, scale-up, and tech transfer for clinical manufacturing. Additional duties involve supporting IND/IMPD and other regulatory filings, authoring technical reports, and contributing to ongoing platform improvement and technology development within the upstream workflow.

Responsibilities will include, but are not limited to, the following:

• Developing high-performance upstream process for recombinant protein production including complex Fusion proteins, Bi-specific antibodies and Antibody Drug Conjugates.

• Using sound scientific and engineering methodologies to establish robust upstream process platform as well as toolbox for early-stage programs. Working closely with Cell Line Development (CLD) and Downstream Process Development (DSP) to streamline overall workflow.

• Leading projects/initiatives related to continuous improvement or development of new approaches/technologies of strategic importance within the department.

• Applying Quality by Design (QbD) principles as appropriate in process characterization study for late-stage programs. Jointly developing suitable control strategy for commercial process.

• Leading pilot scale runs with single-use bioreactor for scale-up test as well as material generation for other functions including GLP toxicity study.

• Supporting tech transfer activities to internal Clinical manufacturing operations as well as external CMOs including performing risk assessment and developing appropriate mitigation strategies. Provide PIP support for manufacturing activities and troubleshooting efforts when needed.

• Participating as a DS representative in cross-functional CMC teams including external CMO to help advance the program in a timely manner to reach milestones.

• Evaluating new technology including external collaborations for improved process understanding. 

• Developing appropriate IP strategies to ensure FTO and to create and strengthen our patent estate in the field.

• Writing technical summary and development reports for efficient knowledge management and regulatory filing support.

• Publishing or presenting scientific findings in peer-reviewed journals or conferences and contributing to industrial collaborations.<