Bristol Myers Squibb
Senior Principal Scientist, Upstream Process Development
Bristol Myers Squibb, New Brunswick, New Jersey, us, 08933
Senior Principal Scientist, Upstream Process Development
Location: New Brunswick, NJ or Summit West, NJ. The Biologics Development group at Bristol Myers Squibb is recruiting for a Senior Principal Scientist in Upstream Process Development. This role leads a team supporting upstream process development projects, overseeing clone selection, platform fit, process optimization, characterization, scale-up, and tech transfer for clinical manufacturing. The position supports IND/IMPD and other regulatory filings, authors technical reports, and contributes to platform improvement and technology development within the upstream workflow.
Overview Our Biologics Development team develops and transfers safe, efficient, and approvable biologics drug substance manufacturing processes and analytical methods for BMS\' biologics portfolio. We collaborate across units to support the clinical pipeline through late-stage development, focusing on efficiency, speed, robustness, and approvability of processes and methods.
Responsibilities
Develop high-performance upstream processes for recombinant protein production, including complex Fusion proteins, Bi-specific antibodies, and Antibody Drug Conjugates.
Establish robust upstream process platforms and toolkits, collaborating with Cell Line Development (CLD) and Downstream Process Development (DSP) to streamline workflows.
Lead projects related to continuous improvement or the development of new approaches/technologies of strategic importance within the department.
Apply Quality by Design (QbD) principles in process characterization studies for late-stage programs and jointly develop suitable control strategies for commercial processes.
Lead pilot-scale runs with single-use bioreactors for scale-up testing and material generation for other functions, including GLP toxicity studies.
Support tech transfer activities to internal Clinical manufacturing operations and external CMOs, perform risk assessments, and develop mitigation strategies; provide Process/Industrialization/Process Improvement (PIP) support for manufacturing activities and troubleshooting as needed.
Participate as a DS representative in cross-functional CMC teams, including external CMOs, to advance programs toward milestones.
Evaluate new technologies and external collaborations to improve process understanding.
Develop IP strategies to ensure freedom-to-operate and strengthen the patent estate in the field.
Write technical summaries and development reports for knowledge management and regulatory filing support.
Publish or present scientific findings in peer-reviewed journals or conferences and contribute to industrial collaborations.
Provide coaching and feedback to develop team members and departmental colleagues.
Qualifications
Ph.D. (6–8 years), M.S. (9–12 years), or B.S. (12–15 years) in Chemical Engineering, Biological Sciences, or a related field with relevant industry experience.
Skills/Knowledge
Strong track record in design, development, and implementation of industrial cell culture processes for recombinant protein production, including Bi-specific and fusion proteins.
Hands-on experience with upstream laboratory activities, high-throughput mini-bioreactors, and pilot-scale single-use bioreactors.
Knowledge of bioreactor characterization and engineering principles (mass transfer, mixing, shear) and fundamentals of biochemistry and cell metabolism.
Understanding of cell culture media, batch/fed-batch/perfusion processes, and media interactions.
Experience with technology transfer and scale-up to GMP facilities, including PIP and troubleshooting support.
Familiarity with PAT, molecular biology, and omics tools to characterize cell physiology and relate to process performance and product quality attributes.
Knowledge of late-stage process development, process characterization, and control strategies; familiarity with CMC timelines and cross-functional collaboration (CLD, DSP, Analytical, Manufacturing, MS&T, Regulatory).
Ability to evaluate and introduce new technologies to accelerate upstream development and improve efficiency.
Strong project leadership, resource management, and excellent verbal/written communication skills.
Adaptable to a fast-paced environment.
Compensation and Benefits Compensation varies by location. New Brunswick, NJ: $148,330 – $179,745; Summit West, NJ: $148,330 – $179,745. Starting compensation is based on experience with potential incentive cash and stock opportunities. Benefits include medical, dental, vision, 401(k), disability and life insurance, paid leave, parental and caregiver benefits, tuition reimbursement, and more. Benefits are subject to plan terms and eligibility.
Additional Information On-site/work model: Site-essential or hybrid options may apply based on role. Equal Employment Opportunity and accommodations information available on careers site. Vaccination policy and local regulations may apply. Data privacy policies for role applications apply.
P.S. If you come across a role that intrigues you but doesn\'t perfectly line up with your resume, we encourage you to apply anyway.
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Overview Our Biologics Development team develops and transfers safe, efficient, and approvable biologics drug substance manufacturing processes and analytical methods for BMS\' biologics portfolio. We collaborate across units to support the clinical pipeline through late-stage development, focusing on efficiency, speed, robustness, and approvability of processes and methods.
Responsibilities
Develop high-performance upstream processes for recombinant protein production, including complex Fusion proteins, Bi-specific antibodies, and Antibody Drug Conjugates.
Establish robust upstream process platforms and toolkits, collaborating with Cell Line Development (CLD) and Downstream Process Development (DSP) to streamline workflows.
Lead projects related to continuous improvement or the development of new approaches/technologies of strategic importance within the department.
Apply Quality by Design (QbD) principles in process characterization studies for late-stage programs and jointly develop suitable control strategies for commercial processes.
Lead pilot-scale runs with single-use bioreactors for scale-up testing and material generation for other functions, including GLP toxicity studies.
Support tech transfer activities to internal Clinical manufacturing operations and external CMOs, perform risk assessments, and develop mitigation strategies; provide Process/Industrialization/Process Improvement (PIP) support for manufacturing activities and troubleshooting as needed.
Participate as a DS representative in cross-functional CMC teams, including external CMOs, to advance programs toward milestones.
Evaluate new technologies and external collaborations to improve process understanding.
Develop IP strategies to ensure freedom-to-operate and strengthen the patent estate in the field.
Write technical summaries and development reports for knowledge management and regulatory filing support.
Publish or present scientific findings in peer-reviewed journals or conferences and contribute to industrial collaborations.
Provide coaching and feedback to develop team members and departmental colleagues.
Qualifications
Ph.D. (6–8 years), M.S. (9–12 years), or B.S. (12–15 years) in Chemical Engineering, Biological Sciences, or a related field with relevant industry experience.
Skills/Knowledge
Strong track record in design, development, and implementation of industrial cell culture processes for recombinant protein production, including Bi-specific and fusion proteins.
Hands-on experience with upstream laboratory activities, high-throughput mini-bioreactors, and pilot-scale single-use bioreactors.
Knowledge of bioreactor characterization and engineering principles (mass transfer, mixing, shear) and fundamentals of biochemistry and cell metabolism.
Understanding of cell culture media, batch/fed-batch/perfusion processes, and media interactions.
Experience with technology transfer and scale-up to GMP facilities, including PIP and troubleshooting support.
Familiarity with PAT, molecular biology, and omics tools to characterize cell physiology and relate to process performance and product quality attributes.
Knowledge of late-stage process development, process characterization, and control strategies; familiarity with CMC timelines and cross-functional collaboration (CLD, DSP, Analytical, Manufacturing, MS&T, Regulatory).
Ability to evaluate and introduce new technologies to accelerate upstream development and improve efficiency.
Strong project leadership, resource management, and excellent verbal/written communication skills.
Adaptable to a fast-paced environment.
Compensation and Benefits Compensation varies by location. New Brunswick, NJ: $148,330 – $179,745; Summit West, NJ: $148,330 – $179,745. Starting compensation is based on experience with potential incentive cash and stock opportunities. Benefits include medical, dental, vision, 401(k), disability and life insurance, paid leave, parental and caregiver benefits, tuition reimbursement, and more. Benefits are subject to plan terms and eligibility.
Additional Information On-site/work model: Site-essential or hybrid options may apply based on role. Equal Employment Opportunity and accommodations information available on careers site. Vaccination policy and local regulations may apply. Data privacy policies for role applications apply.
P.S. If you come across a role that intrigues you but doesn\'t perfectly line up with your resume, we encourage you to apply anyway.
#J-18808-Ljbffr