Sr. Manager, Value Stream CAR-T Manufacturing in Summit, NJ

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 purpose of the Senior Manager, Manufacturing role is to manage and provide oversight of a team of Manufacturing Managers and their Work Centered Teams (WCT) operating in shifts over a 24/7 schedule whose primary responsibility is the execution of Cell Therapy manufacturing processes, maintaining a culture of safety, compliance, innovation, and Continuous Improvement

within the Manufacturing Operations function.

This position reports to Associate Director, Manufacturing

Shifts Available:

Monday – Friday, Night Shift – exact hours TBD

Responsibilities:

Values

• Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion

GMP

• Is accountable to ensure their Manufacturing Managers and their WCT members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMP’s) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Responsible to own, review, author, or approve SOP, WI, master batch records.

Safety

• Takes personal responsibility to work safely and to ensure their managers and WCT members do the same.
• Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior.
• Operates and maintains equipment to prevent injuries or incidents.

Documentation

• Is accountable for the Production Records produced by their Manufacturing Managers and WCT members.
• Performs batch record reviews (BRR) or Electronic Batch Record review by exception.
• Ensures that all documentation produced by their Managers and WCTs follows the ALCOA+ principles.
• Ensures the documentation produced by their Manufacturing Managers and WCT members is right first time, and all records and logbooks are complete and accurate.
• Resolve documentation errors and corrections as needed to enforce manufacturing turnaround times.

Process Expertise

• Is required to perform Cell Therapy manufacturing to maintain hands on expert knowledge of each Unit Operation, demonstrate what good execution looks like to new managers and WCT members and when necessary, back fills for absent team members or makes up the execution resource requirements to meet the production schedule.
• Supports Material Review Board (MRB) data collection and provides process expertise when required to support the MRB decision making process.
• Rotates weekend coverage for manufacturing operations and is first line support for any technical or manufacturing issues during weekend coverage.
• Continues to develop expertise in the field of CAR – T Manufacturing and regulatory requirements that pertain CAR T manufacturing.

Resource Management

• Is responsible to provide the Production Scheduling team with