Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Overview

Bristol Myers Squibb is seeking a Senior Manager of CAR-T Manufacturing. The Senior Manager will support the scale-up and commercial licensure of the Devens CAR-T facility. In addition, the Senior 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 Devens Manufacturing Leadership Team.

Duties and Responsibilities

* Establishes and manages the Devens CAR-T Manufacturing 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 Devens Manufacturing Plant. This includes:
* Establishing department goals, tracking and reporting KPIs, and driving a culture 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.

Qualifications and Requirements

* Bachelors 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.

Required 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
* 4+ years supervising staff in a management role.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.