Description

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 Description:

The Bioassay Center of Excellence is the global center for potency assay development, biological characterization and clinical lot release for biotherapeutics.  This leadership role in the Bioassay Center of Excellence will drive development of state-of-the art bioassays that support the company portfolio of preclinical and clinical-stage biologics.  This position reports to the Head, Bioassay Center of Excellence within the Biologics Development organization.  The role calls for close collaboration with early discovery groups, process sciences groups, internal analytical functions, Manufacturing Sciences and Technology, and Quality organizations.  The candidate will be accountable for direct supervision of scientific staff and strong collaboration with stakeholders.

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

• Oversight and accountability for biological assay development for key milestones from de-novo development through proof-of-concept for cell-based functional assays and immunoassays
• Develop biological characterization strategy for protein therapeutics pre- and post-IND through licensure
• Develop sound scientific strategy to support regulatory acceptance of biological assays in clinical development
• Directs optimization, validation, and transfer of validated methods to commercial quality laboratories and CROs
• Participate in associated CMC activities such as biological comparability and structure-function assessments of protein therapeutics
• Lead a diverse scientist population, develop talent, inspire innovation and operational excellence.  Foster a continuous learning environment

Requirements

• PhD in immunology, cell biology, molecular biology or equivalent experience
• Depth of understanding of molecular mechanism of action for protein therapeutics
• Broad technical knowledge of biological assay development across multiple molecular modalities
• Minimum of 8 years directly related experience in biopharmaceutical development
• Knowledge of cGxP requirements
• Experience with analytical method validation and global regulatory filing requirements
• Experience with cell line engineering and surface plasmon resonance preferred
• Strong history of rigorous science applied to drive technical accomplishments
• Demonstrated leadership capabilities to develop a high-performing team, drive change and influence internal and external stakeholders
• Strong organizational and project management skills
• Strong interpersonal and communication skills
• Track record of scientific accomplishments and publications