CAR-T Cell Therapy Manufacturing Senior Manager

MSCCN; Harvard (MA); On-site; USD 132,000 - 160,000; Full time

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Senior Manager for Cell Therapy Manufacturing to lead clinical and commercial CAR-T production, supervise manufacturing teams, and ensure adherence to cGMP.

The role covers 24/7 operations, hiring and mentoring staff, training, cross-functional collaboration with Quality, Supply Chain, MS&T, EHS and Facilities, establishing KPIs, and driving Lean initiatives.

Qualifications

• Bachelor’s degree in relevant science or engineering discipline, or equivalent in work experience.
• Knowledge of Lean Manufacturing principles required.
• 8+ years of relevant work experience within pharmaceutical or a similarly regulated industry.
• 6+ years supervising staff in a management role.
• BMSCART.

Responsibilities

• Serves as manufacturing functional area owner and manages commercial and clinical manufacturing teams and areas.
• Hiring, mentoring and developing exceptional people.
• Conducting performance reviews and identifying opportunities for career growth for supervisors and associates.
• Championing a culture of exceptional teamwork and communication across the organization.
• Ensuring people have and maintain the appropriate level of training necessary for CAR‑T GMP manufacturing in a multi‑product commercial facility.
• Building effective cross‑functional relationships with Quality, Supply Chain, MS&T, EHS and F&E.
• Ensuring a culture that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements. Models these behaviors every day.
• Plans for and executes commercial and clinical operations for a licensed CAR‑T product in the Devens CTF Manufacturing Plant.
• Establishing department goals, tracking and reporting KPIs, and driving a culture continuous improvement through innovation and implementing lean manufacturing initiatives.
• Authoring, reviewing and approving documents, including standard operating procedures, batch records, material specifications, training materials and validation protocols / reports.
• Developing and communicating project goals, strategy and timeline with manufacturing management.
• Implementing and operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Ensuring schedules of the people, facility, equipment, materials, and documents are established and maintained to support the expected capacity of the facility for multiple CAR‑T products.
• Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
• Championing inspection readiness efforts and initiatives for Right First‑Time manufacturing.
• Establishing team policies, organizational structure, shift structure, and career ladders for Associates, Team Leaders, Supervisors and Managers.

Skills

People leadership

Lean manufacturing

cGMP

Quality systems

Safety culture

Education

Bachelor’s degree in relevant science or engineering

Job description

Bristol Myers Squibb in Devens, MA is seeking a Senior Manager for Cell Therapy Manufacturing to lead clinical and commercial CAR-T production, supervise manufacturing teams, and ensure adherence to cGMP.

The role covers 24/7 operations, hiring and mentoring staff, training, cross-functional collaboration with Quality, Supply Chain, MS&T, EHS and Facilities, establishing KPIs, and driving Lean initiatives.