What are the responsibilities and job description for the Director, Cell Therapy Manufacturing position at Garuda Therapeutics?
The Director is responsible for leading a team in the successful manufacture of stem cells, driving performance, and establishing a culture that achieves operational excellence. Collaborate with business partners to ensure reliable, expandable, and consistent cells are produced in our GMP clean rooms. The Director of Manufacturing must ensure quality and compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices.
Role and Responsibilities:
- Lead a GMP cell culture manufacturing team, focusing on operations enabling a high success rate and minimizing deviations
- Supervise activities and monitor performance of manufacturing team members, providing clear guidance and coaching and necessary
- Ensure clean room and manufacturing areas, team, and equipment are compliant to all GMP and regulatory requirements
- Ensure GMP training status for team members for readiness and compliance
- Investigate and resolve deviations, identifying root cause, and proposing process improvements through the CAPA system using clear communication and expertise
- Ensure timely closure of deviations, CAPA’s, change control support and continuous improvement initiatives
Qualifications:
- MS/PhD is preferred with prior experience managing a cell culture manufacturing team
- 8 years of biotech experience in a scientific, production, or manufacturing setting, including deep eukaryotic cell culture experience
- Prior experience handling iPSC’s is strongly desired
- Experience operating under regulatory requirements, Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
- Expert knowledge of electronic quality systems
- Ability to adapt and pivot in a dynamic and constantly evolving environment
- Ability to work weekends as needed