This Head of Manufacturing opportunity is with a leading gene therapy company who are based in Amsterdam.  They are one of the leaders in the market because of their success in having the first approved therapy in Western world, first commercially licensed manufacturing facility and their effective AAV based technology.  They are seeking a Head of Manufacturing to oversee and drive forwards the production of existing therapies for clinical trials.  Plus, the manufacture of new concepts as they seek to develop new therapies to reach the clinic.

This role will offer you

• Lead the manufacturing department- which is key in the delivery of products, their yield and quality.

• The Head of Manufacturing is central to their operations interacting with Process Development, Quality and Regulatory each day.

• Lead the transfer in of new processes successfully.

• This is a key role in their plans to grow the manufacturing operations, with influence on how this is achieved.

• Drive the optimisation of existing processes and the adoption of new technologies.

You will be responsible for

• Ensuring the manufacturing operations are scheduled and run-in line with the company’s goals and objectives

• Certify manufactured products are in line with GMP, requirements for clinical trials such as IND and NDA regulations.

• Review manufacturing data to ensure team is operating as expected.

• Collaborate with Process Development for the transfer and scale up of new processes.

• Ensures all resources are used effectively and efficiently e.g., people, facilities, supplies etc.

• Responsible for the hiring, retention, development, and training of the team.

• Identification of training needs within the group, motivating the team to achieve goals.

• Develop operating plans, budgets, set goals and monitor these.

You will bring the following

• Hold a scientific or engineering degree.

• Experience of leading manufacturing operations in a Biopharma or AAV or Gene Therapy environment.

• Experience of leading, motivating, and training teams.

• GMP experience along with understanding of QC and QMS.

• Experience of growing operations and teams.

BioTalent Ltd are acting as an employment agency in relation to this opportunity. To find out more about this exciting opportunity, james.hume@biotalent.com with your CV.