Cell Therapy Manufacturing Associate


Zurich, Switzerland

Reporting to: GMP Production Manager

Role

The Manufacturing Associate will be part of our team at
Canal Side Studios, in London, and the Cell and Gene Therapy Catapult
Manufacturing Centre, in Stevenage.

The post holder must be able to support the efficient
delivery of T-cell therapy products for clinical use. The job responsibilities
include GMP manufacturing of cell formulations in cleanroom, process
development work for new clinical trial products and creation of documents
including batch records, SOPs and validation/qualification plans and reports.

The person will be based full time in Stevenage with a
requirement to travel to London when required.

Responsibilities

  • Perform all tasks associated with the manufacture and QC
    testing of Advanced Therapy Investigational Medicinal Products following batch
    records and SOPs
  • Work as part of a small team to manufacture clinical product
    to GMP in close collaboration with Global Manufacturing and Quality
  • Assist in the development and execution of SOPs,
    Qualification and Validation plans and records and deviation CAPA reports
  • Prepare and complete batch records including calculations,
    cross-checking results and review
  • Successfully troubleshoot processing and equipment issues
  • Contribute to laboratory maintenance; specifically cleaning
    and organising clean room to relevant EU GMP and HTA standards and stock
    management
  • Carry out other duties as assigned

Educational and Experience

Essential

(internal training will be provided as necessary)

  • 2 or more years of cGMP experience in an aseptic manufacturing pharmaceutical/biotechnology environment or equivilant experience
  • Cell culture processing experience
  • Demonstrated knowledge of pharmaceutical manufacturing of
    biotechnology products, aseptic processing, cell culture products
  • Experience in performing quality control testing assays,
    including multi-colour flow cytometry, cell counting & microscopic assays
  • Strict adherence to SOPs and cGMP regulations, the ability
    to accurately complete documentation associated with clinical manufacturing
  • Excellent aseptic/sterile techniques and prior experience
    with cell culture, cell culture equipment
  • Experience with handling and propagation of human primary
    cells, including T cells

Desirable

  • Previous experience with cell therapy products is a plus
  • Technology transfer and set up of a GMP compliant facility
  • Experience and knowledge of viral vector based systems and
    their use in gene transduction techniques
  • Knowledge of process development
  • Experience in scientific data mining and analysis using
    Microsoft word , Excel and advanced software such as Graph Pad Prism.
  • Experiment design related to process development and
    scientific report writing

Personal Attributes

  • Ability to think critically, and demonstrated
    troubleshooting and problem-solving skills
  • Self-motivated and willing to accept temporary
    responsibilities outside of initial job description
  • Excellent interpersonal, verbal and written communication
    skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with
    minimal direction and able to adjust workload based upon changing priorities
  • Ability to work off-shift and long hours as required

The job posting may be closed early if we receive a high volume of appropriate CVs so please apply at your earliest convenience.

This job description is subject to change at any time.


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