Responsible for supervising daily operations within the manufacturing cell processing area, ensuring compliance with GMP standards, efficient production workflows, and team performance.
Requirements
- Direct supervision of manufacturing personnel including coaching, training, and performance evaluations.
- Oversee production schedules, batch documentation, and ERP transactions to ensure timely and accurate processing.
- Ensure compliance with GMP, FDA, EMA, and other regulatory standards.
- Monitor production processes and adjust schedules as needed.
- Perform cGMP manufacturing tasks in an aseptic manner in an aseptic environment.
- Enforce safety protocols and procedures to ensure a safe working environment.
- Coordinate with cross-functional teams including Supply Chain, Process Development, and Quality Assurance.
- Maintain audit readiness and support internal and external audits.
- Monitor and report key performance indicators such as batch release timelines and error rates.
- Collaborate with Senior Management in a dynamic environment, demonstrating outstanding communication skills.