Bristol Myers Squibb

Senior Principal Scientist, Upstream Process Development

Bristol Myers Squibb

full-time

Posted on:

Location Type: Office

Location: New Brunswick • New Jersey • 🇺🇸 United States

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Salary

💰 $148,330 - $179,745 per year

Job Level

Senior

About the role

  • Lead a team supporting upstream process development projects for biologics pipeline.
  • Oversee clone selection, platform fit, process optimization, characterization, scale-up, and tech transfer for clinical manufacturing.
  • Develop high-performance upstream processes for recombinant proteins, complex fusion proteins, bi-specific antibodies, and ADCs.
  • Apply scientific and engineering methodologies to establish robust upstream process platforms and toolboxes for early-stage programs.
  • Work closely with Cell Line Development and Downstream Process Development to streamline workflow.
  • Lead projects/initiatives related to continuous improvement and development of new strategic technologies.
  • Apply Quality by Design principles in process characterization studies and jointly develop control strategies for commercial processes.
  • Lead pilot scale runs with single-use bioreactors for scale-up testing and material generation for other functions.
  • Support tech transfer to internal clinical manufacturing operations and external CMOs, including risk assessments and mitigation strategies.
  • Provide PIP support for manufacturing activities and troubleshooting when needed.
  • Participate as a DS representative in cross-functional CMC teams to advance programs and meet milestones.
  • Evaluate new technologies and external collaborations to improve process understanding and efficiency.
  • Develop appropriate IP strategies to ensure freedom to operate and strengthen patent estate.
  • Write technical summaries and development reports to support knowledge management and regulatory filings.
  • Publish or present scientific findings and contribute to industrial collaborations.
  • Manage, coach, and develop team members and departmental colleagues.

Requirements

  • 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.
  • 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.).
  • Robust understanding of biochemistry and cell metabolic pathways.
  • Deep knowledge in cell culture media composition, preparation, analysis, and cell-media interactions; knowledge 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 and correlate to product quality attributes.
  • Familiarity with late-stage process development activities including process characterization and control strategy.
  • Familiar with CMC timelines and cross-functional collaborations (CLD, DSP, Analytical development, Manufacturing, MS&T, Regulatory).
  • Demonstrated ability to evaluate and introduce new technologies to accelerate upstream process development and improve process efficiency.
  • Strong project leadership and resource management skills.
  • Excellent verbal and written communication skills.
  • Adaptable and flexible to a fast-paced environment.
Benefits
  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
  • Paid national holidays and optional holidays.
  • Global Shutdown Days between Christmas and New Year’s holiday.
  • Up to 120 hours of paid vacation.
  • Up to two (2) paid days to volunteer.
  • Sick time off and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
  • Tuition reimbursement and a recognition program.
  • Additional incentive cash and stock opportunities (based on eligibility).

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
upstream process developmentclone selectionprocess optimizationcharacterizationscale-uptech transferbioreactor operationcell culture processesbiochemistrycell metabolic pathways
Soft skills
project leadershipresource managementcommunicationadaptabilityflexibility
Certifications
Ph.D.M.S.B.S.