Supervisor Manufacturing About the Role

The team is organized around critical unit operations such as media preparation, cell selection, activation, and harvesting. You act as both an operational leader and technical expert, fostering a culture of safety, quality, and continuous improvement.

Key Responsibilities Leadership & Team Management

• Lead, coach, and develop a team within cell therapy manufacturing
• Foster a culture of teamwork, accountability, and open communication
• Implement and maintain appropriate training curricula
• Serve as a role model within the organization and peer group

Operational Excellence

• Plan, assign, and oversee daily manufacturing operations
• Ensure all activities are executed in compliance with cGMP requirements
• Maintain compliant, efficient, and safe production and storage areas
• Participate in process troubleshooting and continuous improvement initiatives
• Drive Right-First-Time performance and operational excellence

Quality & Compliance

• Manage the creation, implementation, and compliance of SOPs, procedures, and policies
• Initiate and manage change controls, deviations, and investigations
• Identify strategic and operational risks and implement CAPAs
• Ensure compliance within validated manufacturing systems

Stakeholder & Project Management

• Coordinate operational activities and communicate progress to key stakeholders
• Ensure timely execution of projects and initiatives
• Act as a key operations representative in cross-functional collaborations

Safety & Emergency Response

• Serve as Head of the Emergency Response Team
• Promote a strong culture of safety for employees and patients
• Ensure compliance with all safety regulations and procedures

Qualifications Required

• Minimum 7+ years of experience in cGMP manufacturing (cell therapy, bioprocessing, or related field)
• Minimum 3+ years of leadership experience
• Solid understanding of GMP, quality systems, and manufacturing operations
• Strong communication, leadership, and organizational skills

Preferred Experience

• Hands-on experience in cell therapy manufacturing
• Aseptic processing in ISO 5 biosafety cabinets
• Experience working in BSL-2 / ML-1 environments with human-derived materials
• Experience with:
  • Cell expansion (incubators and single-use bioreactors)
  • Cell washing processes and separation techniques
  • Cryopreservation processes and equipment

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