(Day 6am-6pm) Manufacturing Manager, Cell Therapy Facility

Bristol-Myers Squibb - Devens, MA

Full-time - Mid Level

Devens, MA

Chemical Manufacturing

About the position

Bristol Myers Squibb is seeking a Manufacturing Manager for its new Cell Therapy facility in Devens, MA. This role is pivotal in supporting the start-up and commercial licensure of the facility, which operates 24/7. The Manufacturing Manager will oversee manufacturing associates and ensure that all operations are compliant with current Good Manufacturing Practices (cGMP). This position is not just about managing processes; it’s about leading a team in a challenging and meaningful environment that directly impacts patient lives. The manager will be responsible for creating, implementing, and ensuring compliance with all documentation, procedures, and policies related to manufacturing operations. This includes maintaining a safe and efficient working environment, identifying strategic and operational issues, and leading corrective actions to prevent deviations from established protocols. The Manufacturing Manager will also coordinate with various departments, including Quality Assurance, Global Supply, and Planning, to ensure that operations run smoothly and efficiently. This role requires a strong focus on teamwork, open communication, and a culture of safety and compliance. The manager will oversee daily operations, ensuring that all manufacturing associates are trained and equipped to perform their tasks in a compliant manner. Additionally, the role involves writing and maintaining manufacturing operating procedures that are technically sound and compliant with cGMP requirements. The successful candidate will be responsible for hiring, mentoring, and developing exceptional talent within the manufacturing team, conducting performance reviews, and identifying opportunities for career growth. This position requires shift work, including weekends and holidays, and involves working in a clean room environment with exposure to human blood components and strong magnets. The work is both challenging and rewarding, offering the opportunity to contribute to life-changing therapies for patients.

Responsibilities

• Manage the creation, implementation, and compliance for all documentation, procedures, and policies.
• Operate within the requirements of validated manufacturing systems, planning, assigning, and overseeing daily operational activities.
• Maintain operating and storage areas that are compliant, efficient, effective, and safe.
• Identify strategic and operational issues to prevent deviations and maintain a compliant environment.
• Lead and manage the development of corrective and preventative actions, deviation responses, and investigations.
• Manage implementation and maintenance of appropriate training curricula.
• Create an environment of teamwork, open communication, and a sense of urgency.
• Foster a culture of safety and compliance that embraces safety in the work environment and for patients.
• Efficiently coordinate, communicate, and provide Operations project information and activities status to associated functions in a timely manner.
• Oversee operators on a daily basis as they perform unit operations and support operations described in standard operating procedures and batch records.
• Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification, and validation activities.
• Write manufacturing operating procedures that are technically sound and comply with cGMP requirements.
• Hire, mentor, and develop exceptional people, conducting performance reviews and identifying opportunities for career growth.

Requirements

• Bachelor's degree in a relevant science or engineering discipline, or equivalent work experience.
• 5+ years of experience in cGMP biologics cell culture manufacturing.
• Experience in cell therapy manufacturing is highly preferred.
• Experience with aseptic processing in ISO 5 biosafety cabinets and handling human-derived materials in BSL-2 containment areas.
• Knowledge of cell expansion using incubators and single-use bioreactors, cell washing processes, cell separation techniques, and cryopreservation processes and equipment.

Nice-to-haves

• Experience in a leadership role within a manufacturing environment.
• Familiarity with regulatory compliance and quality assurance processes in a manufacturing setting.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional development and career growth.
• Flexible work environment with a focus on work-life balance.