Head of External Manufacturing

Walker Cole International is searching for a Head of External Manufacturing to join an industry leading biotech business in the UK to lead all externalised manufacturing for a portfolio of ATMPs 

Your responsibilities as the Head of External Manufacturing will be:

• Work with external partners on process/analytical development and manufacturing of clinical stage biologic drug product
• Define strategic use of contract development and manufacturing organisations.
• Support in the authoring of relevant regulatory documents for IND/BLA/MAA
• Oversee technology transfer of processes to contract manufacturers.
• Drive commercialisation initiatives and execute product launch when reached

To be a successful candidate for the Head of External Manufacturing role:

• Degree in a scientific subject (Immunology, Molecular biology, Biotechnology or similar) – PhD preferred.
• Deep expertise in developing biologic and/or ATMP manufacturing procedures
• Proven track record of tech transfer and managing contract manufacturing organisations in industry.

External Manufacturing Director | CMC | Biopharma | Biopharmaceutical | ISO13485 | Gene Therapy | GMP | MABS | Antibodies | CDMO | External Supply | Tech Transfer | Cell Therapy