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.
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. The GMP Quality Manager will play a key role in establishing, growing and maintaining the quality systems and processes to support the expansion of operations for GMP production. A hands-on approach is essential, and it is expected that the successful candidate will work with the clinical, regulatory, QC and manufacturing teams to implement and develop key documents.
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.
• Support Quality Director in build of Achilles QMS, ensuring activities conform with requirements
• Perform routine QA duties to ensure GMP & HTA compliance plus other regulatory requirements relating to manufacture of Autologous ATIMPs including:
o document control system
o change controls
o corrective and preventative actions (CAPA)
o deviation & out of specification (OOS) reporting
o complaint and recall handling
o calibration and maintenance
o qualification & validation
o internal and external audits including vendor /supplier qualification
o batch record review prior to QP certification
o Draft, review and approve Quality and GxP related documentation
o Manage Product Specification Files for ATIMP’s
• Reviewing and approving validation protocols and reports and working with the manufacturing team to establish key manufacturing documentation
• Selection and implementation of eQMS to support GxP activities and wider business
• Key input into QMS policies and plans
This position requires:
• 7+ years’ experience in developing and maintaining regulated quality systems.
• 5+ years’ experience working in a pharmaceutical GMP or Medical equivalent environment
• 3+ years working in Quality role on MIA/MIA IMP or HTA licenced site
• Experience in ATIMPs and/or aseptically manufactured product
• Experience in setting up and managing robust GxP compliant eQuality Management systems
• Able to write/author SOPs, WIs and plans/reports to support clinical trial manufacturing operations
• Demonstrable experience in planning, managing and executing vendor, raw material and site audits
• Experience of working with third party contract manufacturing and testing organisations
• Experience with Clean rooms and ISO14644 requirements
• Demonstrable experience in Facility, Systems and Equipment qualification activities
• Technical expertise/knowledge of quality requirements for manufacturing processes and laboratory techniques
• Pragmatic, hands on approach with operational mindset
• Good English Language reading, writing and communication skills
• Good working knowledge of using Microsoft Office programmes
This position also requires:
• BSc or MSc in a chemical or biological subject
• Formal auditor qualification is desirable
• DI experience is desirable
• Thorough understanding of HTA requirements and Tissues and Cells Directive
• A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
• Good understanding of GCP requirements
• Experience of training staff and building and managing small team
• Experience with Clean room and facility design
• Experience with Clinical manufacturing operations
• Ability to manage multiple projects and prioritise to support business
• Ability to work independently with minimal supervision or guidance
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.