Senior Principal Scientist, Upstream Process Development

Principal Scientist Position

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.
• Ability to manage and provide effective coaching and feedback to help develop team members and departmental colleagues.

Qualifications:

• Ph.D. (68 years), M.S. (912 years), or B.S. (1215 years) in Chemical Engineering, Biological Sciences, or a related field with relevant industry experience.

Skills/Knowledge Required:

• Proven track record of accomplishments in the design, development, and implementation of industrial cell culture processes for recombinant protein production, including bi-specific and fusion protein experience.
• Extensive hands-on experience with upstream laboratory activities including the operation of high throughput mini-bioreactors as well as pilot scale single-use bioreactor systems.
• Knowledge of bioreactor characterization and engineering principles (mass transfer, mixing, shear, etc.) as well as robust understanding of biochemistry and cell metabolic pathways is a must.
• Deep knowledge in cell culture media composition, preparation, analysis, cell-media interactions as well as differential needs of batch, fed-batch, and perfusion applications.
• Demonstrated experience with technology transfer and scale-up to GMP manufacturing facility including providing PIP and trouble-shooting support.
• Familiarity with PAT, molecular cell biology and Omics tools and/or assays to characterize cell physiology changes and correlate to cell culture performance or product quality attributes.
• Familiarity with late-stage process development activities including process characterization and control strategy.
• Familiar with CMC timelines and cross-functional collaborations including CLD, DSP, Analytical development, Manufacturing, MS&T, Regulatory among others.
• Demonstrated ability to evaluate and introduce new technologies to accelerate upstream process development and improve process efficiency.
• Strong project leadership and excellent resource management skills.
• Excellent verbal and written communication skills.
• Adaptable and flexible to a fast-paced environment.