Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner. 

Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Summarised Purpose:

• Support the validation and implementation of immunoassay methods for soluble biomarker analysis in early-stage clinical studies (e.g. enabling and first-time-in-human) 
• Perform sample analysis and be accountable for delivering biomarker results to study teams in a timely manner, following data integrity guidelines and procedures informed by applicable government regulations, relevant SOPs/guidelines
• Ensure full compliance with GCP regulations 
• Generate and review analytical methods, reports, report contributions, SOPs and other relevant documentation
• Facilitate the day-to-day operations of the lab via equipment/consumable/reagent management and liasing with laboratory support services 
• Support and contribute to process improvements (scientific, regulatory/quality) 
• Maintain a safe work environment consistent with local client policies

 
Required Skills and Experience:

• Graduate (or higher) degree in biology, biochemistry, chemistry or pharmacology
• Experience running bioanalytical or biomarker studies in a GxP regulated environment with a focus on good record keeping and data integrity 
• Experience performing quantitative immunoassays using one or more of the following: MSD, ELISA, SIMOA

 
Preferred Qualifications:

• Understanding of regulatory aspects of human biological sample management and Good Clinical Practice (GCP) 
• Experience using Laboratory Information Management Systems (LIMS) e.g. Watson