Manager, CAR-T Selection Operations

Job Description

Purpose and Scope of Position:

Bristol Myers Squibb is seeking a Manager of CAR-T Manufacturing for a new product implementation in S12. The Manager will support the scale-up and commercial licensure of the Summit West CAR-T facility. In addition, the Manager will be responsible for the people manufacturing both clinical and commercial product. This person will be a key leader responsible for GMP operations and will serve as a member of the S12 Manufacturing Leadership Team. This position will manage 4 shifts that cover 24/7 operations for the Selection portion of the new CAR T production process. Start and end times for this position are subject to change based on business demands.

Duties and Responsibilities:

• Establishes and manages the S12 CAR-T Selection team. This includes:
  • 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 Facilities.
  • 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.
• Participates in the Engineering Runs, Tech Transfer Runs and clinical operations for a new CAR-T product in the S12 Manufacturing Plant. This includes:
  • Establishing department goals, tracking and reporting KPIs, and driving a culture of continuous improvement through innovation and implementing lean manufacturing initiatives.
  • 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.
  • Ensuring on time closure of deviations, CAPAs, and change controls.
  • Championing inspection readiness efforts and initiatives for Right First-Time manufacturing.
  • Establishing team policies, organizational structure, shift structure, and career ladders for associates and Team Leaders.
  • Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.

Required Competencies:

Education and Experience

• Bachelor’s degree in relevant science or engineering discipline, or equivalent in work experience. Advanced degree preferred.
• Knowledge of Lean Manufacturing principles required.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Ability to work in the vicinity of strong magnets.
• 7-10 years of experience in cGMP biologics manufacturing, experience in cell therapy manufacturing preferred.
• 4+ years supervising staff in a management role.

Knowledge/ Skills, and Abilities:

• Advanced understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques
• Knowledge of cGMP/FDA regulated industry
• Technical writing capability and experience with writing and approving SOPs, Batch Records, Change Controls, deviations and CAPAs.
• Proficient in MS Office applications
• Background to include an understanding of biology, chemistry, medical or clinical practices
• Previous experience managing, coaching, and providing direction to manufacturing staff with proven track record of developing exceptional teams