Sr Manager, Cell Therapy Manufacturing - Devens MA

Military Spouse Corporate Career Network•Devens, MA

9d•Onsite

About The Position

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 Senior Manager, Cell Therapy Manufacturing supports the clinical and commercial operations of the facility. The Senior Manager will be responsible for the people manufacturing both clinical and commercial product with oversight of shifts that cover 24/7 cell therapy manufacturing unit operations such as media preparation, cell selection, cell processing, or product fill, all of which are executed in accordance with Current Good Manufacturing Practices (cGMP’s).

Requirements

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

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.
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.