GROUP LEADER BIOASSAY (Job Number: 1401237)
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.
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 need.
The Group Leader, Bioassay Development has the opportunity to drive state-of-the art potency assay applications that support the company’s portfolio of preclinical, clinical- stage and commercial biologics. The role calls for close collaboration with early discovery groups, process sciences groups, internal analytical functions, as well as with Manufacturing Sciences and Technology and the Clinical as well as commercial Quality Control organization. This position reports directly to the Director of the Bioassay and Immunoassay Center of Excellence within the Biologics Development organization.
- Directly accountable for bioassay applications for early and late stage development programs, assay qualification/validation, troubleshooting, direct supervision of scientific staff, and strong collaboration with stakeholders in partner organizations.
- Leads a diverse scientist population, develops talent, inspires innovation and operational excellence and fosters a continuous learning environment.
- Leads clinical cGMP organization and oversees technical support activities for commercial biotech drugs.
- Authors technical sections in regulatory submissions.
- Translates strategy into actionable objectives, and anticipates and address technical, regulatory, and other business needs.
•PhD in immunology, cell biology, molecular biology or equivalent field
•Candidates with exceptional demonstrated experience and non-PhD degrees will also be considered
•Typically at least 8 years directly applicable experience in biopharmaceuticals
•Strong technical knowledge of cell-based bioassays for CMC applications
•cGxP experience and a sense for compliance
•Proven technical leader
•Strong history of rigorous technical accomplishments
•Strong interpersonal and communication skills
•Demonstrated knowledge in biological assays for CMC applications
•Understanding of regulatory and industry guidelines in the area of potency assay development and validation
•Experience in interactions with Health authorities (FDA, EMEA etc) is advantageous
•Demonstrated leadership capabilities to develop a high performing team, drive change and influence internal and external stakeholders
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