Principal Scientist, Upstream Process Development (R1556843-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
We are currently seeking a Principal Scientist to join Bristol Myers Squibb Biologics Development group in New Brunswick, New Jersey. The Principal Scientist in Global Upstream Bio-Process Development will be working in a dynamic team setting across cell line, upstream/downstream process development, and analytical groups to develop highly efficient and robust upstream processes to support BMSs biologics pipeline. The candidate will be responsible for leading/supporting upstream development projects for upstream process development, main activities include clone selection, platform fit and process optimization, process characterization, scale-up and tech transfer for clinical manufacturing. The candidate will be responsible for supporting IND/IMPD/BLA filings with authoring high quality technical reports. The candidate will also contribute to continued platform improvement and technology development efforts to further the upstream development workflow.
Ph.D. in Chemical Engineering, Biological Sciences, or relevant disciplines, with minimum 5 years of relevant industrial experience or MS with minimum of 10 years relevant industrial experience or BS with minimum of 15 years relevant industrial experience
Responsibilities will include, but are not limited to, the following:
Developing high-performance upstream process for recombinant protein production including complicated fusion proteins and bi-specific antibodies. 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. 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. Providing supervision and mentorship to junior scientists or associates.
- Proven track record of accomplishments in the design, development, and implementation of industrial cell culture processes for recombinant protein production. Bi-specific experience is a plus.
- 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. Media development experience is a plus.
- Demonstrated experience with technology transfer and scale-up to GMP manufacturing facility including providing PIP and trouble-shooting support.
- 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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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