Scientist/ Analytical Team Lead (I)

Manufacturing/Ops

icon-location-marker New Brunswick - NJ - US
Posted 68 days ago Full_time R1520991

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.

Scientist/ Analytical Team Lead (I), Bioassay Development – Bioassay Center of Excellence

Description:

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/ Analytical Team Lead, 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. The role also offers an opportunity for analytical project management in an Analytical Team Lead function for Biologics.

Responsibilities:

  • 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
  • Translate analytical strategy into actionable objectives, and anticipate and address technical, regulatory, and other business needs.

Qualifications:

  • 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
  • Experience in Immunoassay development
  • Diverse experience with biological systems is advantageous
  • Molecular and Cell Biology experience is advantageous
  • 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
  • Project management experience for CMC projects in Biologics would be advantageous.

    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.