GMP Production Scientist

  • Achilles Therapeutics
  • Job type: Permanent
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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.

Role Summary:
We are seeking a bright, enthusiastic and motivated GMP production scientist with experience in the field of Advanced Therapeutics Medicinal Products (ATMPs) to join our growing multi-disciplinary team and support the development of a next generation personalised cancer medicines. As a GMP production scientist you will support the technology transfer, validation and clinical production of Achilles Therapeutics ATMP pipeline within the CCGTT GMP clean rooms based at Royal Free Hospital and work 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.

Responsibilities
• Support GMP activity for the manufacture of ATMPs to 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.
• Assist 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.
• Perform ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards.
• Assist in coordination of production scheduling activity, labelling, packaging and distribution of starting materials, raw materials and final drug product.
• Coordinate activities with QC to ensure appropriate and timely sampling and testing of raw materials, in-process samples and finished product.
• Be accountable to the head of production for all production operations.

Desirable Experience
• MSC in a Biological Science discipline.
• 5 years’ experience in a scientific laboratory role.
• 3 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 development 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, with a competitive salary and benefits package to match seniority and experience. The company has laboratories in London and Stevenage UK.

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

Apply now

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