Scientist, Upstream Process Development Full-time

Scientist Position In Upstream Biologics Development

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.

Location Devens, MA

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.

Job Description:

We are seeking enthusiastic candidates to fill a Scientist position within Bristol Myers Squibb in the Upstream Biologics Development group located in Devens, Massachusetts. This group is part of the larger GUCLD (Global Upstream and Cell Line Development) organization. GUCLD's primary function is to efficiently develop high performing, productive upstream cell culture processes. This position participates in fundamental areas such as clone selection, platform fit, process optimization, process characterization, scale-up and tech transfer to clinical manufacturing. The successful candidate should have solid fundamentals in mammalian cell culture (or in specialized, but applicable fields), creativity and high motivation as the group's function also includes continued platform evolution and technology development efforts. The environment is highly collaborative and matrixed with colleagues in cell line development, downstream process development, analytical groups as well as with manufacturing, and MS&T organizations. The candidate will be responsible for conceptualizing, supporting and leading upstream development projects. Excellent verbal and written communication skills are critical as responsibilities include scientific presentations and authoring high quality technical reports as well as support of regulatory filings. This position offers the successful candidate many excellent opportunities to learn and grow their career in biologics process development.

Responsibilities will include, but are not limited to, the following:

• Develop high-performance upstream processes for recombinant protein production inclusive of monoclonal antibodies, complex fusion proteins, bi-specific antibodies, antibody drug conjugates using the BMS platform process with modifications as needed for robust performance.
• Collaborate closely with cell line development, downstream process development and analytical groups to streamline overall workflows.
• Apply Quality by Design (QbD) principles as appropriate in process development and characterizations. Jointly develop suitable control strategies for commercial processing.
• Support tech transfer activities to pilot scale and clinical manufacturing operations, both internal and externally to CMOs. Perform risk assessment and develop appropriate mitigation strategies. Provide PIP support for manufacturing activities and troubleshooting efforts as needed.
• Participate as a DS upstream representative in cross-functional CMC teams to advance programs in a timely manner.
• Using sound scientific and engineering methodologies, explore methods and new technologies to evolve the upstream process platform for both early and late-stage programs.
• Drive external collaborations to improve processes and understanding. Developing appropriate IP strategies to ensure FTO and pursue patent opportunities.
• Present technical summaries to peers and upper management as well as technical writing for development reports, and regulatory filing support.
• Publish and/or present scientific findings in peer-reviewed journals or conferences and participation in industrial collaborations.
• Provide supervision and mentorship to junior scientists or associates.

Qualifications:

• Ph.D. (0–2 years), M.S. (2–4 years), or B.S. (5–7 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 and principles for recombinant protein production.
• Knowledge and/or experience with more complex proteins (fusion proteins, ADCs, etc.) are plusses.
• Hands-on experience with upstream laboratory activities including the operation of high throughput mini-bioreactors and familiarity with benchtop and pilot/ manufacturing scale single-use bioreactor systems.
• Knowledge of bioreactor characterization and engineering principles affecting scale-up (mass transfer, mixing, shear, etc.) as well as robust understanding of biochemistry and cell metabolic pathways are essential.
• Specialized experience in one or more areas as applied to mammalian upstream process development, examples include: media development, cell and protein analysis techniques, omics techniques, relevant application of statistics, DoE, modeling / machine learning, etc.
• Demonstrated ability identifying and evaluating new technologies to accelerate upstream process development and improve process efficiency.
• Ability to troubleshoot, solve problems and think critically.
• Basic understanding for bioprocessing in a GMP environment.
• Demonstrated experience of strong performance working both independently and in team settings is essential.
• Strong project leadership and excellent resource management skills.
• Excellent verbal and written communication skills.