Principal Scientist, Bioanalysis

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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.

POSITION

Principal Scientist - Bioanalysis (Biologics)

Location

Lawrenceville, NJ

PREREQUISITES

Ph.D. in biological or related sciences

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.

Responsibilities include:
  • Development, validation, and the conduct of ligand binding and molecular assays to support pharmacokinetic (PK) and immunogenicity assessments for biologics programs (CAR-T, Mab, ADC, fusion proteins, and peptides).
  • Manage the bioanalytical portion of non-clinical and clinical studies for biologics conducted at contract research organizations (CROs).
  • Compile and interpret pharmacokinetic and immunogenicity data.
  • Author and review: protocols, bioanalytical reports, and regulatory documents.
  • Prepare responses to regulatory agencies related to bioanalysis.
  • Represent NDB on cross-functional biotherapeutics discovery and/or development teams.
  • Oversee reagent development to support bioanalytical programs (ie, antibodies for assays and cell lines to support NAB analysis)
  • Evaluate new technologies for analysis of large molecules and implement as needed.


Skills/Knowledge Required :
  • Ph.D. in biological sciences or related discipline with >8 years’ experience
  • Excellent interpersonal, written, and oral communication skills
  • Experience managing the bioanalytical portion of non-clinical and clinical studies for biologics conducted at CROs
  • Experience preparing regulatory documents related to the bioanalysis
  • Detailed knowledge of qPCR, ddPCR, ELISA, and cell-based assays as applied to bioanalysis
  • Understanding of the drug development process for biologics, especially as it applies to bioanalysis
  • Extensive PK/ADA/Nab assay problem solving and analytical skills; ability to resolve technical issues during method development, assay validation, and sample analysis
  • Strong understanding of the scientific/regulatory standards for bioanalysis of biologics
  • Proven track record of performing large molecule bioanalytical sample analysis and performing bioanalytical method validation in a GLP environment
  • Prior experience working on cross-functional drug development teams
  • Proven record of peer-reviewed publications in the relevant technical areas


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.

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