Tech Transfer Specialist - GMP Biologics

SLS Services Limited; Cambridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the Cell & Gene Therapy sector is seeking a Tech Transfer Specialist to manage the transfer of scalable manufacturing processes into a high-tech facility. This role requires demonstrable experience in GMP manufacturing and strong understanding of both upstream and downstream processing. Candidates will be responsible for ensuring project goals are met while collaborating with internal teams and external Contract Manufacturing Organizations.

Qualifications

• 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.

Responsibilities

• Manage the end-to-end transfer of internal and external tech transfer activities.
• Collaborate with Innovation Team and Process Development groups.
• Ensure timely delivery of project goals with external CMOs.
• Oversee the transfer of processes 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.

Skills

GMP manufacturing of ATMPs

Upstream processing

Downstream processing

Cell culture of human or mammalian cell lines

Writing Batch Records

Education

BSc or higher qualification in a relevant life science field

Job description

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.