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Associate Director, Ms&t Site Lead
3 months ago
**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.
**Title**:Associate Director, MS&T Site Lead**
**Location: Summit, NJ**
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 **Associate Director of Manufacturing, Science, and Technology **at the S6A Clinical Manufacturing site leads a team responsible for supporting the production of Gene Delivery/ Editing assets for clinical trials. Oversees the technical manufacturing support, new product introduction, technology transfer, and lifecycle management of clinical programs. Provides technical, compliance, and continuous improvement support to the production operations to ensure rapid, flawless, and cost-effective delivery of quality products.
The individual will manage and execute multiple parallel projects aligned with department goals. Plans project(s) objectives and priorities. Manages multiple tasks efficiently and resolves competing priorities. Establishes timelines, and goals for tech transfer tools and drives efficiency. The individual will be part of the Clinical Manufacturing leadership team overseeing a group of technical teams and support. He/ she will also have experience with equipment selection, with support of equipment qualification activities. BMS evolving Gene
- therapy teams will allow for high throughput, highly productive cGMP manufacturing operations fueling a fast-paced environment. This position offers an experienced individual a significant opportunity to establish best practices for technical support of cGMP manufacturing operations and help expand the group to enable new technology execution.
**Responsibilities**
Ensure safe and compliant cGMP operations.
- Interface with regulatory authorities as required to support Manufacturing Operations audits.
- Foster a culture of compliance and strong environmental, health, and safety performance.
- Own technical and compliance risk assessments.
- Liaise with teams both within CTDO and outside the network (gMSAT, external vendors, supplier quality, etc.) to ensure all materials, equipment, and processes are compliant.
Support the Senior Director in developing productivity with the cross-functional team.
- Implement metrics to track and manage the completion of objectives and projects.
- Monitor the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management.
- Drive strong collaboration within the operation teams and across the network.
- Cascade organizational strategic goals and objectives that are linked to the overall company strategy.
- Deliver business results through timely and quality decision-making and advice.
- Participate in the above site activities that pertain to scale-up, product accelerations, lessons learned, etc.
Support Clinical Production Activities.
- Continuously monitor, anticipate, and permanently resolve issues that may arise during production.
- Support investigations, ensuring compliance with internal standards and regulatory requirements.
- Monitor plant performance metrics and support plant operating review meetings.
- Support the life cycle management of each clinical program, including execution of change controls and managing all activities.
- Lead facility fit, the introduction of new products, including the technical transfer, and S6A manufacturing readiness activities.
- Develop tools and templates for the tech transfer activities to facilitate accelerations.
- Lead clinical investigations of all manufacturing operations root cause investigations, CAPAs, and Change Controls.
Lead Site MSAT Team.
- Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel, and equipment are in place.
- Stay current with industry trends and standards and participate in best practice forums consistent with function responsibilities.
- Select and develop a well-trained, motivated, and informed staff.
- Build trust and effective relationships with peers and stakeholders.
- Create an environment of
