Key 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
• This position will require shift work, including holidays and weekends.
• This position may require you to work in a clean room environment, with exposure to human blood components and in close proximity to strong magnets.

Required Background and Experience:

• Bachelors in relevant science or engineering discipline, or equivalent in work experience.
• 5+ years of experience in cGMP biologics cell culture manufacturing
• 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.
• Have previous leadership/supervisory experience
• Can prioritize multiple assignments and changing priorities