NIGHT SHIFT: Manager, Cell Therapy Manufacturing in Devens, MA

Role Summary

The Manager will lead 24/7 cell therapy manufacturing operations at a Devens, MA facility, supporting the start-up and commercial licensure of the cell therapy site. The role oversees manufacturing associates across rotating night shifts and coordinates with Planning, Quality Assurance, Global Supply and other functions to ensure compliant, safe, and efficient operations. This position requires strong cGMP knowledge, documentation control, training oversight, and cross-functional leadership to advance cell therapy manufacturing at the site.

Responsibilities

• Manage the creation, implementation and compliance for all documentation, procedures and policies
• Operate within the requirements of validated manufacturing systems, plan, assign and oversee daily operational activities associated with assigned areas of responsibility
• 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 the safety of the patients by compliance with company procedures and policies, and cGMP requirements
• Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner in accordance to schedules and defined implementation timelines
• Oversee operators on daily basis as they
  • Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner
  • Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
  • Maintain training assignments to ensure the necessary technical skills and knowledge
  • Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification and validation activities
  • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Hire, mentor and develop exceptional people. Conduct performance reviews and identify opportunities for career growth for manufacturing associates
• This position will require shift work, including holidays and weekends
• This position will require you to work in a clean room environment, with exposure to human blood components and in close proximity to strong magnets

Qualifications

• Required: 5+ years of experience in cGMP biologics cell culture manufacturing
• Preferred: Cell therapy manufacturing
• Preferred: Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 containment areas
• Preferred: Cell expansion using incubators and single-use bioreactors, cell washing processes, cell separation techniques and cryopreservation processes and equipment

Skills

• Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements
• Demonstrated advanced technical writing skills
• Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical
• Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects
• Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills

Education

• Bachelor’s in relevant science or engineering discipline, or equivalent in work experience

Additional Requirements

• Work in a clean room environment with exposure to human blood components and in close proximity to strong magnets