Head Of Regulated Lab

The Client
  
I have partnered with a fast growing biotech research and diagnostics company who are hiring a number of Scientific positions. They are based in West London.
  
The Role
  • Lead on Regulated Core Lab Services Programme
  • Validate mass spectrometry assays to relevant clinical standard (ISO15189, CLIA, GCLP)
  • Assess and validate additional assay platforms (i.e NuLISA)
  • Independently applies scientific principles to achieve project objectives, including the design and execution of complex experiments, and analysis and interpretation of data under limited supervision
  • Assessing viability and feasibility of new assays
  • Execute project deliverables for biomarker studies in clinical trials by project scope of work and within sponsor-specific timelines
  • Manage day-to-day operational aspects of clinical biomarker projects.
  • Assist in preparation and adherence to trial documents i.e., Project Protocols, Data Transmittal Forms etc.
  • Ensure project documentation are complete and stored appropriately.
  
About You
  • Degree in biochemistry/related subject essential
  • 5+ years’ experience in mass spectrometry operation and method development
  • Experience in delivery of mass spectrometry biomarker projects desirable
  • Quality Assurance/Compliance in clinical trials settings;
  • Experience in Clinical trials/mass spectrometry in a clinical environment desirable