Job Summary
The Senior Director of Manufacturing plays a pivotal role in steering the evolution of cell therapy production from the clinical phase to commercial operations. This individual will be responsible for the execution of GMP manufacturing and preparing the facility for operational readiness. The position calls for the creation of a scalable manufacturing framework while fostering collaborative relationships across various departments and ensuring adherence to regulatory requirements.
Responsibilities
- Oversee the transition of cell therapy operations towards commercial launch.
- Ensure execution of GMP manufacturing processes and facility preparedness.
- Develop a manufacturing organization capable of scaling operations effectively.
- Manage cross-functional teams and partnerships to enhance operational efficiency.
- Guarantee compliance with all relevant regulatory standards and guidelines.
Qualifications
- A minimum of 15-20 years of experience in biotechnology bioprocessing and GMP manufacturing.
- Specific expertise in cell or tissue therapy manufacturing is essential.
- A degree in Molecular Biology, Immunology, Biotechnology, or a closely related discipline.
- Demonstrated experience in technology transfer and the startup of commercial facilities.
