Principle QC Scientist- Cell Therapy- London
A fantastic opportunity has arisen for a Principle QC Scientist to join an expanding clinical stage biotechnology company based in London. As an organisation they are committed to developing next generation cell therapies, bringing together strong expertise across oncology, bioinformatics and cellular therapy. This is a superb opportunity to join a fast-moving, innovative company who are going places, and to make a real impact in the early stages.
As the Principle QC Scientist you will lead a small QC team who are responsible for performing all QC related assays for in-process control and final release testing (flow cytometric, ELISpot). You will develop strategy for the team and take a lead in implementing QC documentation and assay validation in line with GMP for advanced therapies. In addition, you will play a key role in supporting both the tech transfer and process development teams on all QC related activity to enable introduction of new manufacturing processes and analytical techniques.
* Manage QC activities for tech transfer and manufacture of ATMP
* Perform routine QC duties and prepare documentation to ensure GxP & MHRA compliance plus other regulatory requirements relating to manufacture and clinical trials for cellular therapies and ATIMPs
* Oversee qualification and validation of equipment and assays
* To review analytical and laboratory data for accuracy, completeness and compliance with documented procedures
* Management of QC compendial testing e.g. endotoxin, mycoplasma, sterility and environmental monitoring.
* Manage junior members of the QC team
* Degree in a relevant scientific subject
* Strong experience in a QC and GMP environment
* Technical expertise with immunoassays including flow cytometry and ELISpot
* Experience in qualification and validation of equipment and assays
* Experience in preparing SOPs, Qualification and Validation documents
* Experience of training and managing staff
* Knowledge of QC compendial testing (endotoxin, mycoplasma and sterility testing)
* Knowledge of biopharmaceutical and cell-based techniques including immunohistochemistry, PCR, DNA/RNA isolation, cytotoxicity and cell proliferation assays.
To find out more about this superb opportunity please contact myself, Lauren Gripton, of Paramount Recruitment on email@example.com
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
Job Reference: Lg7856_1554194201
Broadcast As: 196
Salary To: Negotiable
Job Type: Full Time
Job Term: Permanent
Job Industry: Biotech
Job Specialism: Science R and D
Recruitment Consultant: Lauren Gripton