Principal Scientist Upstream Process Development

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

POSITION

Principal Scientist, Upstream Process Development

SUPERVISOR

Director, Upstream Process Development

DEPARTMENT

Biologics Development and Manufacturing

PREREQUISITES

Ph.D. in Chemical Engineering, Biological Sciences, or relevant disciplines, with minimum 10 years of relevant industrial experience or MS with minimum of 15 years relevant industrial experience or BS with minimum of 20 years relevant industrial experience

This Principal Scientist position will be responsible for the development of robust and scalable upstream processes for production of recombinant proteins. The successful applicant will be leading a small group of scientists and associates, and should have the ability to establish mutual respect, trust, and close collaborations with internal and external partners.

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.

Skills/Knowledge Required :


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.


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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1524602_EN

Updated: 2020-04-30 00:00:00.000 UTC

Location: Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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