Manager Expansion CAR-T Operations

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Purpose and Scope of Position:

BMS is seeking a Manager of CAR-T Manufacturing to oversee ide cel Expansion operations in S12. The Manager will support clinical operations 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 Expansion portion of the ide cel 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 Expansion 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.













Manages expansion activities for clinical and commercial ide cel operations 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.

Participates as an SME during Agency inspections.


Required Competencies:

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


Qualifications and Requirements


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, hands and arms.

7-10 years of experience in cGMP biologics manufacturing, experience in cell therapy manufacturing preferred.

2-4 years supervising staff in a management role. Managing or supervising CAR T operations is preferred.


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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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