Associate Director, CAR-T Process Engineering, Systems and Technology Support

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. 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, CAR-T Process Engineering, Systems, & Technology Support leads a team of scientists and process and/or systems engineers that support clinical and commercial cell therapy manufacturing.  This team is responsible for product and process monitoring, troubleshooting, and improving clinical and commercial cell therapy unit operations and process systems records. This position reports to the Director of Process Engineering within the site Manufacturing Sciences and Technology organization.

Shifts Available:

Monday - Friday, 8am - 5pm (additional availability for escalations as needed)

Responsibilities:

• Leads a team of process subject matter experts that support clinical and commercial cell therapy manufacturing operations. 
• Provides on call, 24/7 manufacturing support for clinical and commercial production for run the business and continuous improvements or roll out of required system and process updates in alignment with the network
• Establishes and maintains the site’s process monitoring program. Collaborates with other sites and global teams on the continued process verification program and brand APQR.
• Identify, prioritize and drive continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production. Promote problem identification and the creation of meaningful solutions through a culture of proactive problem prevention
• Reviews and approves manufacturing batch records and procedures
• Reviews and approves process investigations and change controls
• Engage and align CMC lifecycle strategy and execution with stakeholders
• Influence and review technical content within the CMC sections of regulatory filings
• Build and cultivate for the team and site a culture of maintaining a constant state of inspectional readiness
• Function as a primary contact for internal and Health Authority audits and driving audit observation corrective actions to closure
• Serve as MS&T representative on cross-functional and multi-site teams
• Build and maintain effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs
• Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.  Exercise sound judgment and flexibility while adapting to rapidly changing priorities, challenging situations, and deadlines needed to meet business objectives
• Coach and mentor team members thereby enabling their development and career growth
• Establish and track departmental performance metrics

Knowledge, Skills, Abilities:

• 12+ years relevant experience in cGMP environment for Biologics/CMC/Vaccines
• 4+ years managing direct reports with varying levels of experience
• Ability to prioritize and provide clear direction to team members in a highly dynamic environment
• Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Experience with internal and health authority audits
• Excellent verbal/written communication skills and ability to influence a