About Achilles Therapeutics:
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.
The Principle QC Scientist will lead a small team supporting GMP operations with responsibility for performing all QC related assays for in-process control and final release testing of Achilles T cell therapies (flow cytometric, ELISpot) that are entering the clinic later this year in a phase I/II trial. The candidate will be responsible for developing the strategy of the team with senior members of the company and leading on implementation of all QC documentation and assay validation in line with EU GMP for advanced therapies. In the addition the Principle QC Scientist will lead on supporting both the tech transfer and process development teams on all QC related activity to enable introduction of new manufacturing processes and analytical techniques. As well as developing and growing the team going forward in line with approved budgets.
A hands-on approach is essential, and it is expected that the successful candidate will work with the quality, regulatory 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.
• Work closely with the Head of GMP Production and The Director of Quality to establish operations. Processes and systems for QC capabilities
• Manage Achilles QC activities for tech transfer and clinical trial manufacture
• Perform routine QC duties and prepare documentation to ensure GxP & MHRA compliance plus other regulatory requirements relating to the manufacture and of Achilles advanced therapies
• Oversee qualification and validation of equipment and assays
• Select, purchase and qualification of appropriate QC laboratory equipment
• To review analytical and laboratory data for accuracy, completeness and compliance with documented procedures
• Management of QC compendial testing e.g. endotoxin, mycoplasma, sterility and oversee environmental monitoring activities
• Help build, support and manage junior members of the QC team
• Establish and maintain relationships with external QC providers
This position requires:
• 5 years working in a QC and GMP environment, in a pharma/biotech environment
• Technical expertise with immunoassays including flow cytometry and ELISpot
• Experience in qualification and validation of equipment and assays
• Strong understanding and demonstrable experience of the application of GxP requirements including design and implementation of SOPs, Qualification and Validation documents required for a regulated environment
• Experience of training and managing staff
• Knowledge of QC compendial testing (endotoxin, mycoplasma and sterility testing)
• Knowledge of biopharmaceutical and cell-based techniques including immunohistochemistry, PCR, DNA/RNA isolation, cytotoxicity and cell Proliferation Assays
• 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.