Hobson Prior are looking for a Head of Quality Control to join a new manufacturing operations group who focus on the technology and manufacturing of its pioneering immunotherapy products. This role will entail establishing a QC function to enable compliant testing of ATMP’s.
- Set up of a QC function for the company facility based in Stevenage.
- You will make sure QC activities conform with the requirements of both Pharmaceutical Quality Systems.
- Accountable for daily laboratory management including budget control and maintenance/calibration of equipment.
- Represent as the person responsible for Quality Control named on an MHRA license.
- Develop a QC strategy for GMP testing of products in partnership with Research & Development, Process Development teams to ensure required methods are developed, qualified, validated and maintained as appropriate.
- Approval and oversight of external outsourced testing services. Point of contact for QC related activities as required by Quality Technical Agreements with contract partners.
- Ensure QC personnel staffing directly reporting and indirectly reporting are adequately trained and performance is consistent with requirements of GMP compliant operations.
- Perform chemical, biochemical, biological and microbiological testing of final product and starting or raw materials to be utilized in cell therapy manufacturing.
- Oversight of in-process testing conducted by multiskilled manufacturing operators.
- Partaking in investigations related to the quality of the product including Out of Specification events.
- Act in the capacity of technical expert for analytical methodologies to be able to resolve quality control issues and implement timely resolution.
- Review batch testing records review prior to QP release.
- Inform VP Quality and Senior Management of significant QC related matters or risks that could impact product quality, product release or regulatory compliance.
- Can manage a wide range of tasks with minimal direction and prioritising tasks accordingly
- A meticulous eye to detail
- Strong interpersonal and communication skills both written and verbal.
- Highly self-motivated and able to motivate others.
- BSc in cell/molecular biology/immunology or associated sciences.
- Minimum of 8 years’ experience in a Quality Control GMP environment.
- Prior experience in the gene/cellular therapy field with experience of cell-based assays in particular flow cytometry, cell based killing assays and microbiological safety testing.
- Previous experience in analytical method development and validation in a GMP environment to support clinical and commercial programs.
- An understanding of the current state of the art in cell product analytical development and instrumentation, developments and future trends in the field.
- Experience in management of outsourced activities at contract testing laboratories or CMO’s.
- Good knowledge of GMP regulations in the US and/or Europe including those that specifically apply for the testing of cell therapy products and/or ATMP’s.
- Prior experience of writing and/or review of GMP documents (SOP’s, qualification/ validation reports and testing records) to ensure good documentation practice and essential GMP, Quality and regulatory requirements are met.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.