Principal Scientist, Bioassay and Impurity Assay 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. Read more: careers.bms.com/working-with-us.

Principal Scientist, Bioassay and Impurity Assay Development

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

Description:

Bristol Myers Squibb is a global leader in Biotherapeutics for Immuno-Oncology. The Potency and Impurity Analytical Development department serves as the central hub for biological potency assay and impurity assay development, comprehensive biological characterization, and clinical lot release. In support of our expanding biologics pipeline, we are seeking seasoned professionals who are dedicated to advancing recombinant therapeutics to address critical unmet medical needs.

The Principal Scientist will lead the development of advanced potency and impurity assays to support the company’s portfolio of preclinical and clinical-stage biologics. This position demands a deep understanding of cell biology, immunology, and molecular biology, as well as expertise in designing and developing cell-based assays for protein function analysis. Success in this role requires strong collaboration with early discovery, process sciences, analytical teams, Manufacturing Sciences and Technology, and Quality Control.

Responsibilities:

• Serve as the primary lead for bioassay development across both early and late stage development programs, including design and qualification of assays for biological characterization and validation, and partner closely with stakeholders across the organization.

• Oversee experimental planning, execution, data review and analysis, technical documentation, and contribute to regulatory submissions.

• Participate in the formulation of analytical control strategies; proactively address technical, regulatory, and business requirements.

• Ensure comprehensive documentation of results and maintain laboratory instrumentation in compliance with GMP standards.

• Promote innovation, scientific and operational excellence, and continuous learning within the team.

Qualifications:

• PhD in Immunology, Cell Biology, Molecular Biology, or a related scientific discipline with 4–6 years of relevant industry experience; or a Master’s degree with 6–9 years of experience; or a Bachelor’s degree with 9–12 years of experience.

• Typically possesses 4–6+ years of direct experience in biopharmaceutical development.

• Demonstrated strong scientific expertise in cell-based assay development.

• Experience in developing CMC strategies for potency and/or impurities.

• Proficiency in developing ELISA methods for QC lot release of potency and impurities.

• Experience with BIACORE or FACS is highly desirable.

• Detail-oriented and committed to delivering high-quality results.

• Excellent interpersonal and communication skills.

• Knowledge of regulatory and compliance guidelines.

#LI-Onsite

#GPSProdDev

If you come across a role that intrigues you but doesn’t perfec