Associate Technical Director, Vector Steward
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.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
We are looking for an Associate Director, Technical Steward to join our Product Stewardship team in the Global Manufacturing & Technology group here at Bristol Myers Squibb.
Come, join the BMS Cell Therapy Operations (CTO) Division, and be a part of the team leading cell therapy platforms to serve our patients with novel cellular immunotherapies. The Global Manufacturing Science and Technology (GMS&T) Division of CDO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external and internal manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.
We are looking for an Associate Director, Technical Steward to join our Product Stewardship group in Global MS&T to serve as the lead for vector manufacturing for our Breyanzi commercial CAR-T product. The position is located in Summit, NJ; Warren, NJ; Devens, MA; or Seattle, WA.
The Technical Steward role is highly cross functional and challenging, involving leadership across all sites of viral vector manufacture for the designated product. The Technical Steward develops strategy for the product franchise by representing viral vector on product strategy teams, and leading a cross-functional team that manages the viral vector technical project portfolio. The Technical Steward interacts regularly with site and corporate leadership in assessing resources required, communicating progress and risks, and presenting timelines and strategies for endorsement. The Technical Steward represents the viral vector manufacturing process in regulatory interactions such as inspections and other meetings.
The Technical Steward is the primary owner of the viral vector process, and leads or participates in large-scale process validation, regulatory filings, regulatory inspections and responses, technology transfers, troubleshooting, change management, process monitoring and robustness, continuous improvement, and other initiatives. The Technical Steward works with viral vector manufacturing site teams to troubleshoot manufacturing issues and develop process improvements using scale-down models of vector manufacturing. The Technical Steward collaborates closely with others in analytical, quality, regulatory, operations, development, supply chain, program strategy, global validation, third-party manufacturing and manufacturing sciences roles to drive the franchise strategy. The position requires resolution of complex problems through strong leadership of cross-functional teams to meet quality, schedule, and cost objectives.
Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing:
- The primary owner of the viral vector process for the designated product
- Provides technical leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, change control and implementation, product comparability and escalated support of technical/scientific process and analytical issues
- Defines strategy for the product franchise by representing viral vector on product strategy teams, and leads a cross-functional technical team that creates and governs the viral vector technical project portfolio for the designated product
- Provide technical content for significant documents such as PPQ or comparability assessments, author content for regulatory submissions and annual product quality review, present technical strategies during major health authority interactions and inspections
- Collaborates closely with others in analytical, quality, regulatory, operations, development, supply chain, strategy, third party manufacturing and manufacturing sciences roles to drive the brand strategy and prevent supply disruptions
- Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites.
- Oversees implementation of lifecycle management projects and responsible for gaining consensus on change implementation strategies that ensure robust viral vector supply.
Qualifications & Experience
- The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
- Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, manufacturing support and technology transfer.
- Strong knowledge of viral vector upstream (cell culture, transfection) and downstream (clarification, chromatography, tangential flow filtration) unit operations
- Demonstrated leadership skills, and the ability to interact with and lead diverse groups and teams are essential.
- Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team based environment are required
- Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools strongly preferred
- Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment required
- Prior experience facilitating/participating in Risk Assessments preferred
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.
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