A brand-new permanent role has arisen with a leading organisation in Stevenage, Herts, for a QC Manager. You will help build up the company’s growing analytical testing capability, as part of the company’s exciting expansion plans. We are looking for an adaptable, energetic, collaborative, honest and versatile person to join this pioneering company who are at the forefront of T-cell therapy.
This is a permanent position, paying a very generous salary, annual bonus and healthcare, to discuss on application.
You will be based on site in modern premises in Stevenage and will lead a growing QC team, overseeing activities such as tech transfer, equipment monitoring, environmental monitoring, reviewing QC GMP release documents and executing PQs for Flow/nc2oo/ddPCR.
Your role will include:
- Management of QC laboratories and personnel involved in testing and release of clinical products
- Approving or rejecting starting materials, packaging materials, intermediates, bulk and finished products
- Ensuring that all necessary testing is carried out in a timely and compliant manner and that testing records are reviewed and approved to support product release
- Approving specifications, sampling instructions, test methods, procedures and other Quality Control documentation.
- Identifying, selecting, approving and managing contract analytical laboratories involved in finished product testing
- Supporting the review of certificate of analysis and reports for review by Quality Assurance.
- Ensuring that maintenance and qualification of QC facilities, equipment and assays are conducted and approved in line with company procedures
- Designing and implementing assay qualification protocols for in-process and finished product testing and ensure compliance to future ongoing validation activities
- Developing initial training programmes for QC staff and ensure training is delivered to staff as appropriate
- Managing future QC laboratory expansion programmes to include design, build-out and transfer and qualification of essential equipment and assays
- Supporting technology transfer programmes and QC process improvement initiatives to improve efficiency, reduce lead time and manage costs
- Being the named person for Quality Control on the company’s MHRA license.
Skills and Experience Required:
- Experience of establishment, qualification and validation of assays related to cell therapy products such as Flow Cytometry and qPCR gained within ideally in a Biologics, Cell Therapy / ATMP, sterile manufacturing or Biopharmaceutical organisation, regulated to GMP standards
- Life science qualification – ideally a Masters or PhD in Biological Science, Cell Biology or similar
- Excellent communication skills and ability to work with people at all levels
- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. This is a permanent role in Stevenage, Hertfordshire.