Bristol-Myers Squibb is the world leader in Biotherapeutics for Immuno-Oncology. The Bioassay Center of Excellence is the global center for biological potency assay development, biological characterization and clinical lot release. To enable the continuous expansion of our biologics pipeline, we are looking for experienced professionals passionate about bringing recombinant therapeutics to patients to address significant unmet medical needs.
The Scientist, Bioassay Development has the opportunity to drive state-of-the art potency assay development that supports the company's portfolio of preclinical and clinical- stage biologics. The role requires a working understanding and experience with the development of mechanistically relevant biological assays to assess potency in both GMP and non-GMP environments. This function also requires close collaboration with early discovery groups, process sciences groups, internal analytical functions, as well as with Manufacturing Sciences and Technology and the Quality Assurance organization.
* Directly accountable for bioassay development for early and late stage development programs, development of fit-for-purpose biological characterization assays, assay qualification/validation, lot release and stability analysis, and strong collaboration with stakeholders in partner organizations.
* Responsible for experimental design, execution, data review and analysis/interpretation, and document authorship.
* Generates and thoroughly documents results, and maintains instrumentation in a GMP-compliant environment.
* Inspires innovation and operational excellence and fosters a continuous learning environment
* Typically MS in immunology, cell biology, molecular biology or equivalent field with 3-5 years' relevant experience, or BS with 5-10 years' relevant experience
* Experience with the development of cell based in-vitro assays
* Diverse experience with biological systems is advantageous
* Experience in Immunoassay development
* BIAcore/SPR and/or FACS experience is advantageous
* Methodical and committed to high-quality results
* Strong scientific, interpersonal and communication skills
* Awareness of regulatory and compliance guidelines would be advantageous