Manager, Clinical Manufacturing, Cell Therapy in Devens, MA

Role Summary

Manager, Clinical Manufacturing, Cell Therapy

Responsibilities

• Supporting the development, implementation and compliance of manufacturing documentation, procedures and policies.
• Operating within the requirements of a validated manufacturing systems, plan, assign and oversee daily operational activities associated with assigned areas of responsibility.
• Maintaining operating and storage areas that are compliant, efficient, effective and safe.
• Identifying strategic and operational issues to prevent deviations and maintain a compliant environment. Leading and managing the development of corrective and preventative actions, deviation responses and investigations.
• Creating 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 coordinating, communicating, and providing 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.
• Overseeing 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.
• Be trained and proficient for floor operations.
• Hiring, mentoring and developing exceptional people
• Conducting performance reviews and identifying opportunities for career growth for manufacturing associates.

Qualifications

• 5+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Bachelors in relevant science or engineering discipline, or equivalent in work experience.

Knowledge, Skills, Abilities

• Experience in cell therapy manufacturing techniques, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes using incubators and bioreactors, and automated equipment is highly preferred.
• Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas is highly preferred.

Working Conditions

• 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.