Associate Director, Material Review Board Process Owner, Cell Therapy

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 Associate Director, Material Review Board Process Owner is part of the BMS Cell Therapy Quality Systems organization.  At the intersection of people, process, and systems is the Business Process Owner (BPO) network. The BPO for Material Review Board works with an expanding network of internal and external stakeholders to foster cross-site collaboration, harmonize business process and deliver a road map for continuous improvement, systems implementation and help drive decision-making for initiatives associated with Quality inputs/processes related to Material Review Board (MRB) and the Out of Specification (OOS) release process.

The MRB Process Owner is positioned within the Disposition Business Process Owner team. This team is responsible for ensuring that all disposition related processes within Cell Therapy are executing compliantly, efficiently, and in a standardized fashion across the network. While this specific role is focused within the out of specification release workflow, including MRB, initiatives and projects supporting the overall disposition program are also in scope. This is an individual contributor position reporting directly to the Director, Cell Therapy Quality Disposition Process Owner.

The MRB Process Owner works closely with Cell Therapy subject matter experts, legal, regulatory, medical affairs, and IT partners. This is an exciting opportunity to shape how BMS’s Cell Therapy manufacturing network operates and be part of a team influencing the overall future of the Cell Therapy network.

Key Responsibilities:

• Serve as the CTDO Process Owner for MRB

• Lead the MRB Community of Practice

• Partner with franchise on internal and external communications associated with the MRB process

• Support development of Out of Specification Release Processes for new sites, markets and/or indications within the CTDO network

• Develop the strategy and business process road map for Cell Therapy MRB

• Lead, develop and implement policies and procedures based on current regulations and industry standards to ensure readiness for scalability within Cell Therapy

• Partner with cross-functional leaders to ensure compliant and scalable processes.

• Work with senior leaders to help establish performance goals and strategic/operational objectives for MRB and OOS workflows.

• Develop process metrics that can be used to provide performance insights to stakeholders

Qualifications & Experience:

• Bachelor's degree in a life sciences or engineering discipline and a minimum of 7+ years of relevant biotechnology or pharmaceutical industry experience including direct experience with Quality Systems.

• Cell Therapy experience is strongly preferred.

• Experience participating in cross-functional matrix teams.

• Excellent oral and written communication skills. Skilled at presenting complex topics to senior leaders.

• Proven record leading or contributing to projects or programs in support of GXP operations

• Experience with regulatory inspections

• Extensive knowledge of current industry practices

• Experience with interpretation and application of guidelines and regulations

• Proven ability to adjust to multiple demands, shift