Manager, Cell Therapy Manufacturing

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.
• Hiring, mentoring and developing exceptional people.
• Conducting performance reviews and identifying opportunities for career growth for manufacturing associates.

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.

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.

Minimum Requirements

• 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.