Scientific Director, Bioassay Development (R1559582-en-us)
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.
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
- 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
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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