Scientist - Scientific Operations (Client-dedicated)

Thermo Fisher Scientific Inc.; Letchworth; On-site; GBP 32,000 - 42,000; Full time

Job summary

Thermo Fisher Scientific Inc. in Stevenage is seeking a scientist to validate and implement immunoassay methods for soluble biomarker analysis in early-stage clinical studies.

You will perform sample analysis and deliver biomarker results to study teams in a timely manner, following data integrity guidelines and GCP-informed procedures. Within the Analytical Services team, you will generate and review analytical methods, reports, SOPs and other documentation, while supporting day-to-day lab

Qualifications

• Experience running bioanalytical or biomarker studies in a GxP environment with focus on data integrity and record keeping.
• Experience performing quantitative immunoassays using MSD, ELISA or SIMOA.
• Understanding regulatory aspects of human sample management and GCP.

Responsibilities

• Validate and implement immunoassay methods for soluble biomarker analysis in early-stage clinical studies.
• Perform sample analysis and deliver biomarker results to study teams with data integrity.
• Generate and review analytical methods, reports, SOPs and related documentation.
• Facilitate day-to-day lab operations including equipment, consumables and reagent management.
• Maintain a safe work environment consistent with local client policies and contribute to process improvements.

Skills

Bioanalytical experience

GxP/regulatory experience

Data integrity

Education

Biology/biochemistry/chemistry/pharmacology degree

Tools

LIMS (Watson)

Immunoassay techniques (MSD/ELISA/SIMOa)

Job description

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/guidelinesEnsure full compliance with GCP regulations Generate and review analytical methods, reports, report contributions, SOPs and other relevant documentationFacilitate 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 pharmacologyExperience 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

Why Join Us?When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference.Our 4i Values: Integrity - Innovation - Intensity - Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs,

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork - the largest global platform for the LGBTQ+ business community.

Work ScheduleStandard (Mon-Fri)Environmental ConditionsLaboratory SettingJob Description12-Month Fixed-Term OpportunityLocation: Stevenage, fully on siteThermo 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