Tech Transfer Specialist - GMP Biologics

Job Description: This is an exciting opportunity to join a leading company in the Cell & Gene Therapy sector. We are seeking a skilled Tech Transfer Specialist to manage the transfer of scalable manufacturing processes, projects, and knowledge into a state-of-the-art facility. This role offers the chance to play a key role in advancing cutting-edge therapies, including commercial-scale production and government-funded projects.

Purpose of the Role: The Tech Transfer Specialist will oversee the successful transfer of manufacturing processes, projects, and knowledge into a new, high-tech manufacturing site. You will collaborate with internal teams to ensure that all technical processes and projects meet timelines and quality standards.

Key Responsibilities:

• Manage the end-to-end transfer of internal and external tech transfer activities, including outsourced process development and GMP manufacturing processes.

• Collaborate with the Innovation Team and Process Development groups to manage the transfer of scalable manufacturing processes.

• Ensure timely delivery of project goals, working with external Contract Manufacturing Organizations (CMOs) in technical collaboration.

• Oversee the transfer of processes both into and out of the manufacturing facility.

• Maintain the site-wide Quality Management System (QMS).

• Contribute to the design, development, and implementation of key projects at the facility.

Desired

Skills and Experience:

To succeed in this role, candidates should have:

• Demonstrable experience in GMP manufacturing of ATMPs, biologics, or related sectors.

• Strong understanding of both upstream and downstream processing.

• Experience with cell culture of human or mammalian cell lines.

• Experience in the writing of Batch Records or manufacturing protocols.

• A BSc or higher qualification in a relevant life science field.