Senior Principal Scientist, Upstream Process Development
Bristol Myers Squibb
Summit, NJ
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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Location New Brunswick, NJ or Summit West, 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:
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Location New Brunswick, NJ or Summit West, 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.
- Ability to manage and provide effective coaching and feedback to help develop team members and departmental colleagues.
- 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.) 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.
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 2025-09-27
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