Achilles is a fast paced, trail blazing company. We are breaking new ground with our science creating products that have never been made. As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt, and collaborate across our organisation, working together to solve novel problems. This entrepreneurial spirit and approach runs through our company and those who thrive here are able to cope with anything that is thrown at them, enjoy ambiguity and thrive on making things happen even when there is not a detailed brief.
This role is based at the CGT Catapult in Stevenage which is a key facility in manufacturing of the Company’s personalised T cell therapy products for use across Achilles clinical trial programmes.
This role will play a key part in establishing, growing, and maintaining the quality systems and processes to maintain operations for GMP production.
Additionally, ensuring GxP and other regulatory requirements relating to clinical trial manufacture are met and maintained for ATIMPs (Advanced Therapy investigational Medicinal Product).
Responsibilities / Accountable Tasks
- Leading and developing a team of QA professionals with different levels of experience.
- Managing & undertaking routine QA duties relating to the facility, manufacturing process and QC testing of Achilles’ IMPs including activities.
- Document management.
- Creation, review and approve Quality and GMP related documents.
- Deviation management including Risk escalation and investigations.
- Vendor qualification
- Change Control
- Corrective and Preventive Action (CAPA)
- Complaint and Recall handling
- Training
- Qualification & Validation
- Internal Audits and External Audits (as necessary)
- GMP Data review including Regulatory Submission
- Provision of QA GMP and associated in house training activities e.g. SOPs and Forms
- Provide support and data for Achilles Quality Management Reviews, as required.
- Support & managing activities within Achilles QMS, as assigned.
- Enhancement of Achilles QMS, as appropriate
- Managing of Batch Record Review & QP certifications
- Preparation & review of the batches
- QA review from sponsor site
- Preparation & managing of QP certification
Requirements
Essential
- Extensive experience working in QA in a Biotech/Biologics/ATMP GMP Environment, ideally on MIA /MIA IMP Licensed Site
- Demonstratable Technical Knowledge of Aseptic Manufacturing Processes, Sterility Assurance and Laboratory Techniques
- Demonstrable experience of managing a team of QA professionals, providing evidence of support and development of direct reports
- Experience in setting up and managing robust Quality Management systems ensure GxP compliance
- Experience in planning, managing and executing vendor and site audits
- Knowledge about Regulatory Requirements for ATIMPs
- Thorough Understanding of UK, EU, and US GMP Requirements
Desirable
- Good working knowledge of the tissues and cells directive
- Experience of auditing key raw material suppliers as to GMP compliance
- Experience of working with contract manufacturing companies
Benefits
This is a permanent role, offering a competitive benefits package
At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership, and teamwork. We work hard and deliver a lot
Our benefits package includes a competitive salary and performance related bonus, group pension plan matched up to 6%, life insurance, private medical insurance, and a tax approved all employee share incentive plan.
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