Head of GMP Production

Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first product for Non-Small Cell Lung Cancer expected to enter the clinic in 2H 2019.

Role summary

We are seeking a well-qualified and experienced candidate to join our growing manufacturing team at Achilles Therapeutics to support the scale up of manufacturing for the Company’s personalised T cell therapy products for use across Achilles clinical trial programmes. As Head of GMP Production you will support the technology transfer, validation and clinical production of Achilles advanced therapies and also working closely with the product development team to support process engineering activities. If you want to be a part of a well-funded, exciting new start-up, and enjoy playing an active role in supporting the development and clinical manufacture of ATMPs which have the ability to transform the clinical management of cancer, then this is the role for you.

This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Key responsibilities

• Leading GMP activity for the manufacture of Achilles advanced therapy platform and facilitate technology transfer, process validation, equipment validation and qualification, stability studies and materials management.
• Support process engineering activity in closed system cell culture and identifying and implementing procedures in accordance with GMP and regulatory standards.
• Support continued development and in-process improvement activity to streamline process operations and optimisation of manufacturing methods.
• To assist/lead in the preparation and review of GMP documentation including BMRs, SOPs, Change Control, user requirement specifications, process deviations, and risk assessments to ensure the highest levels of controls and traceability.
• Lead operations for ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards.
• Assist/lead in coordination of production scheduling activity, labelling, packaging and distribution of starting materials, raw materials and final drug product.
• To coordinate activities with QC to ensure appropriate and timely sampling and testing of raw materials, in-process samples and finished product.
• Ensure maintenance of GMP cleanroom environment suitable for the manufacture of ATMPs
  Work with external service providers.
• Provide support, leadership and supervision for GMP production scientists

This position requires

• BSC/MSC in a Biological Science discipline.
• 10 years’ experience in a scientific laboratory role.
• Minimum of 5 years’ experience working in a regulated environment (GLP/GCLP/GMP).
• Experience in human cell isolation, and cell and tissue culture in a GMP compliant environment.
• Able to work in a Grade B cleanroom production environment.
• ATMP Process validation experience.
• Understanding of GMP, ATMP, and EUTCD regulations
• Working knowledge of generating process and QC data for regulatory submissions.
• Strongly focused on quality and safety.
• Have excellent planning and organisational and time management skills.
• Have good communication and interpersonal skills
• Self-motivated with strong initiative and drive.

This is a permanent position, based at Achilles HQ in Stevenage with the opportunity to work with the Achilles manufacturing team established at The Royal Free Hospital in London. This position offers a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.