Transformation Unit Laboratory Assistant

5 days ago

London, Greater London, United Kingdom Transformation Unit Full time
Job Title: Transformation Unit Laboratory Assistant

We are seeking a highly skilled and motivated Laboratory Assistant to join our team at the Transformation Unit. As a Laboratory Assistant, you will play a critical role in supporting the manufacture of advanced therapy medicinal products (ATMPs) for the treatment of childhood diseases.

Key Responsibilities:
  • Contribute to the optimization and validation of GMP manufacturing processes applicable to ATMP clinical trials
  • Participate in the manufacturing of ATMP products for clinical trials
  • Validate QC tests relevant to ATMP manufacture
  • Write and implement new BMRs, SOPs, and worksheets
  • Accurately complete GMP documentation related to manufacturing, storage, and shipment of ATMPs
  • Comply with UK MHRA GMP and GCP regulations applying to ATMP manufacturing and conduct of first-into-man clinical trials
  • Contribute to the overall normal activities of the research team and department as required, including laboratory duties and attendance at departmental meetings
  • Ensure that equipment used is safe and maintained in good working order
  • Manage stock control, ordering, and receipt of goods for manufacturing in compliance with GMP regulations, including critical starting materials such as viral vector and leukapheresis
  • Organize shipments to/from external laboratories and completion of relevant documentation
  • Participate in process simulations and media fills
  • Support in liaising with key stakeholders and client organizations to report on progress and delivery against project milestones
Requirements:
  • BSc in Medical Laboratory Science or completion of STP training program or equivalent
  • GCP, GMP, and HTA training
  • Experience of working in a CPA/UKAS accredited laboratory or other related translational laboratory
  • Understanding of the structure of a Pharmacy Quality System for manufacture under an MHRA license
  • Experience of writing and following BMRs, SOPs, and other key manufacturing documents
  • Experience in GMP manufacturing
  • Experience in the manufacture of ATMPs
  • Experience in culture and/or manipulation of human primary cells and cell lines
  • Experience in writing complex documents such as Product Specifications and technical sections for IMPDs
Skills and Abilities:
  • Excellent interpersonal skills
  • Ability to work without supervision
  • Good organizational skills and time management
  • Demonstrated ability to prioritize and meet deadlines
  • Preparation of high-quality written documents
  • Technical aptitude and ability to critically assess and improve processing methods and batch manufacturing

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