Cell Therapy Manufacturing Supervisor

1 week ago

Baltimore, Maryland, United States Medvacon Life Sciences Full time
Job Description

The Cell Therapy Manufacturing Supervisor will oversee 24/7 cell therapy operations, managing manufacturing associates and ensuring compliance with standard operating procedures and regulatory requirements.

Key Responsibilities:
  • Documentation and Compliance: Manage the creation, implementation, and compliance of all documentation, procedures, and policies.
  • Operational Activities: Operate within validated manufacturing systems, plan, assign, and oversee daily operational activities associated with assigned areas of responsibility.
  • Facility Maintenance: Maintain operating and storage areas that are compliant, efficient, effective, and safe.
  • Issue Identification and Resolution: 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.
  • Training and Development: Manage implementation and maintenance of appropriate training curricula.
  • Culture and Communication: 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 patients by compliance with company procedures and policies, and cGMP requirements.
  • Project Coordination: 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 with schedules and defined implementation timelines.
  • Operator Oversight: Oversee operators on a 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.

This position requires shift work, including holidays and weekends. The position may also require working in a clean room environment, with exposure to human blood components and in close proximity to strong magnets.

Required Background and Experience:
  • Bachelor's degree in a relevant science or engineering discipline, or equivalent in work experience.
  • 5+ years of experience in cGMP biologics cell culture manufacturing.
  • Experience in cell therapy manufacturing, aseptic processing in ISO 5 biosafety cabinets, and universal precautions for handling human-derived materials in BSL-2 containment areas is highly preferred.
  • Cell expansion using incubators and single-use bioreactors, cell washing processes, cell separation techniques, and cryopreservation processes and equipment.
  • Previous leadership/supervisory experience and the ability to prioritize multiple assignments and changing priorities are required.

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