Project Design Engineer
Teleflex
Senior Principal Scientist, Upstream Process Development
Bristol Myers Squibb
full-time
Posted on:
Location Type: Office
Location: New Brunswick • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $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).
ATS 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.
