Senior Principal Scientist, Upstream Process Development

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Challenging. Meaningful. Life-changing. Those arent 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. Youll 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.

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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 youll 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 BMSs 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.

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: 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. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years 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. Other perks like tuition reimbursement and a recognition program.

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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

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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.

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