This is a newly-created position with a fast-growing cell therapy organisation in Cambridge, which is going to be applying for an HTA licence and will be implementing a brand-new electronic QMS later in the year. You will grow and lead a QC team and will have a range of duties to provide QC support to Manufacturing and QA departments. We are looking for an energetic, collaborative, honest and versatile person to join a pioneering company at the forefront of synthetic and stem cell biology, manufacturing human cells for research and drug discovery purposes.
This is a permanent position, paying a very generous salary in the region of £60k - £65k, plus excellent benefits. You will be officially based in the company’s modern site in Cambridge, though for time being this role is home-based (until August). You will therefore need to live within commutable distance of Cambridge or be prepared to move to the area in due course.
Reporting to the Head of Quality, your role will include:
- Leading the setup of a QC function, to support in-process QC testing and final product release for a pipeline of cell products for both research purposes and the clinical development pipeline.
- Leading the development of the QC strategy for the generation and validation of analytical test methods, acquisition and qualification of laboratory equipment and reporting and release of materials and final products.
- Collaborating with R&D, Manufacturing, Logistics and Commercial teams to help deliver quality products to market.
- Scheduling the QC workflow, both for off-the-shelf products, client projects and products in clinical development.
- Management and oversight of outsourced QC work programmes.
- Leadership of OOS investigations of material or product.
- Establishing relevant QC KPI’s to monitor conformity and providing status reports to Senior Management at Quality meetings.
- Ensuring quality goals and objectives are cascaded down through the organisation.
- Managing projects and delivering improvements in QC capabilities, efficiency, throughput and compliance.
- Assisting with writing protocols, reports, SOPs and testing documents.
- Supporting the development of the team, by providing relevant training, tools, skills and motivation to provide opportunities for personal improvement and encourage contribution towards continual improvement.
In addition to a generous basic salary, the company offers the following benefits package:
- 30 days holiday
- 5% match contributory pension - after three months
- Private healthcare - with Vitality (the highest level of cover you can get) after three months
- Life assurance
- Cycle to work scheme
- Electric car scheme - coming in soon
Skills and Experience Required:
- Strong experience of Quality Control gained within a commercial Pharmaceutical setting, ideally in a Biologics, Cell Therapy / ATMP or Biopharmaceutical organisation, regulated to GMP (and possibly HTA) standards
- Understanding of a range of analytical techniques (e.g. flow cytometry, sterility testing, PCR, ICC, MEA, karyotyping etc)
- Knowledge of analytical method validation and qualification of lab equipment
- Life science qualification e.g. biochemistry, molecular biology, biochemistry, chemistry etc
- Experience with human induced pluripotent stem cells, characterisation and culture systems would be an advantage but is not essential
- 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 Cambridge, Cambridgeshire, but will be home-based to begin with.