Do you have a passion for Quality, backed with expertise in Molecular Biology, Cell Biology or Stem Cell Biology? Are you a seasoned CMC professional, with significant industry experience in Quality Control for Advanced Therapies, preferably within Cell and Gene Therapy?
If so, this is a genuinely unique opportunity for an ambitious, positive-minded individual, to join a fast-growing cell therapy organisation in Cambridge, which has a unique focus and is at the cutting edge of stem cell innovation.
This is a permanent position for a Senior Scientist, Quality Control, paying around a generous salary and benefits which can be discussed on application. You will be based in the company’s modern site in Cambridge.
Reporting to the Associate Director, QC & GMP Analytical Development, you will be responsible for successfully implementing QC testing for cell banks, starting materials, drug substance, and drug product to support clinical manufacture of a clinical cell therapy candidate. This is an exciting opportunity to contribute to the development of next-generation cell therapies, with cross-functional collaboration with stakeholders across quality, regulatory, and CMC. This will involve active participation in all elements required for successful delivery of a cell therapy testing package, including identification of characterisation and QC tests, CTO and CDMO selection, new technology evaluation, and partnership with analytical development and external partners for assay transfer and qualification.
Leading method transfer, establishment, and qualification of multiple assays for QC release for a novel engineered cell therapy, including flow cytometry, ddPCR and/or qPCR, and cell-based functional assays
Participating in selection of CTOs and CDMOs for compendial and product-specific analytical methods required for testing of starting materials, drug substance, and drug product
Working with analytical development team members to ensure method readiness for transfer to GMP testing labs, including review of method development reports and SOPs
Collaborate with cross-functional external and internal partners
Partnering with quality assurance and regulatory teams to appropriately incorporate current regulations and guidance into the testing approach
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
Cycle to work scheme
Electric car scheme - coming in soon
Skills and Experience Required:
Strong experience of Quality Control gained within a highly regulated setting, ideally in a Biologics, Cell Therapy / ATMP or Biopharmaceutical organisation
Understanding of qPCR or ddPCR
Education in Molecular Biology, Cell Biology, Biological Science, Stem 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 Cambridge, Cambridgeshire.