Gary Niles

Experience

1. Senior Manager Cell Therapy

   Bristol Myers Squibb

   Mar 2021 — Present

   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