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3 weeks ago

Manager Quality Control - Cell therapy - London

London Borough of Camden Competitive Permanent

Job Reference: 4356738

Head of Quality Control – ATMPs / Cell Gene Therapy -  London
  
A superb opportunity has arisen for a Head of GMP Quality Control to join a world- leading clinical organisation based in London.  This is a fantastic opportunity to work with a multitude of different products and collaborate with top academic & biopharma institutions.
  
Reporting into the Director of the facility the Head of Quality Control will be responsible for:
  • - Establishment of a new QC laboratory, to validate existing and new analytical equipment and design and validate new QC assays.
  • - Directly line manage a team and train members in all aspects of QC
  • - QC lab budget management- ensure that the Quality Control Service is adequately staffed and resourced
  • - Perform vendor assurance and critical supplier auditing
  • - Development and validation of all new ATMP manufacturing procedures
  • - Creation of all batch manufacturing records
  • - Contribute to the formulation of patient specific ATMP medicines in response to their individual clinical needs
  • - Review all regulatory agency submission materials
  • - Participate in the development of regulatory strategies and implementation plans for the preparation and submission of new products.  
Requirements
  • - Educated to minimum of MSc level in a relevant field
  • - Strong experience in cell and gene therapy / ATMPs quality control
  • - Ex-vivo culture of human stem cells, multiparametric flow cytometry desirable
  • - Previous leadership experience
  • - Holder of QP status or within training for QP status is desirable- the company are keen to support candidates through QP applications  
In return you can expect to receive a competitive salary, excellent pension scheme and extended holiday allowance. Please do not hesitate to contact Lauren Gripton at lgripton@pararecruit.com / + 44 (0) 121 616 3465
  
Keywords- QC, quality control, QA, quality assurance, regulatory, Bsc, Msc, PhD, cell therapy, cellular therapies, gene therapy, Advanced therapy medicinal products, Investigational Medicinal Products, manager, head, principal, group leader, qualified person, CAR-T.
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