Senior Director, Manufacturing Science and Technology
Bristol Myers SquibbAbout the role
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
The Senior Director, Cell Therapy Manufacturing Technology leads a cross-functional team responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. The Summit, NJ Cell Therapy production facility is a multi-product operation. This role oversees the operations investigation team, product launch, technology transfer, validation and cell therapy Automation / MES. This position provides technical and continuous improvement support to the startup, tech transfer and operation of the Cell Therapy production facility in Summit, NJ to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. This is a critical role to ensure timely qualification of the cell therapy operations (CTO) facility and continued reliable supply. The role will work closely with the global Manufacturing Science &Technology leadership and CMC functions to standardize CTO practices and ensure that the process remains in a validated state.
Shifts Available:
Monday – Friday, Standard Working Hours
Responsibilities:
- Foster a culture of compliance and technical expertise with a foundation of strong environmental, health, and safety performance.
- Build and maintain inspection readiness and actively support regulatory inspections, interface with regulatory authorities as required to support pre-license inspections and subsequent routine GMP inspections.
- Build and evolve the organizational structure to maximize productivity and organizational success in the design, construction, validation, and operation of the Summit Cell Therapy manufacturing facility. Select and develop a well-trained, motivated, and informed staff.
- Develop, implement, and monitor metrics to track and manage completion of objectives and projects.
- Allocate resources to ensure supply plans are met within the planned schedule and budget.
- Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel, and equipment are in place.
- Work with key partner organizations such as Manufacturing, Quality, and Facilities & Engineering to build and maintain efficient systems that support the safe, successful, and compliant startup, technical transfer, and operation of a clinical and commercial Cell Therapy manufacturing facility.
- Collaborate with BMS Network Cell Therapy manufacturing facilities to ensure consistent performance and compliance to meet reliable supply.
- Lead a Validation team that will:
- Provide technical leadership for the commissioning, qualification, and validation of the Summit Cell Therapy manufacturing facility with a focus on clean room technology and Aseptic Qualification.
- Partner with Summit Facilities and Engineering to establish systems that will maintain a compliant, validated state for the Manufacturing facility.
- Lead a team of Automation engineers that will:
- Manage stand-alone manufacturing equipment.
- Support the design, build, deploy, validate, and support both automation and execution systems (Delta V, Syncade, MES, EBR, OSI Pi Data historian, etc.) in a regulated pharmaceutical manufacturing environment.
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