Manager – Cell Therapy Manufacturing

Manager – Cell Therapy Manufacturing

Requirements

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

Responsibilities

• Manage the creation, implementation and compliance for all documentation, procedures and policies
• Operate within the requirements of a 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.

Preferred Qualifications

• Experience in the following is highly preferred: Cell therapy manufacturing, Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 containment areas, Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and cryopreservation processes and equipment.