Head Of Regulated Lab
other jobs Mackie Myers
Added before 7 Days
- England,London,City of London
- Full Time, Permanent
- Salary negotiable
Job Description:
*Fast growing biotech research and diagnostics company
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
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
Job number 3404921
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