Careers at ThermoFisher Scientific

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United Kingdom - Basingstoke
Job Description
Job Title: Senior Product Evaluation Specialist
Position Location: Basingstoke

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

Position Summary

The Senior Product Evaluation Specialist will manage studies of new and existing Microbiology Division (MBD) products in the clinical, food safety and pharmaceutical sectors.

  • Design, coordinate, manage, analyze and report on studies in accordance with regulatory guidelines and business requirements to maximize quality and value of the study and to enable feedback to the business within specified timeframes.
  • Identify suitable potential study sites (current or potential MBD customers, key opinion leaders, etc.) and liaise with these study sites to agree terms and conditions of the study.
  • Compile study protocols for studies of MBD products in accordance with departmental SOPs and other supporting documentation to reflect the requirements of the business.
  • Advise the business on study requirements for products used in a clinical environment (including In Vitro Diagnostic Regulation (IVDR) requirements and other regulatory requirements) and ensure studies are conducted to meet these requirements.
  • Advise the business on method validation requirements to achieve food safety validation (e.g. ISO 16140, AOAC-RI etc.) and ensure studies are conducted to meet these requirements prior to commercialization.
  • Work with food safety validation bodies to achieve compliance with validation requirements at all times.
  • Be accountable for all Product Evaluation Team-related activities within New Product Development and other projects, to include ownership and communication of project plans and risk analysis and mitigation activities for Product Evaluation Team-related activities.
  • Analyse study data and prepare study reports.
  • Present study findings to the business (both written and verbally) where required.
  • Be accountable for and manage Product Evaluation Team spend on individual projects as identified by Manager.
  • Attend and present work at scientific events.
  • Carry out any further tasks that are reasonably requested by Manager.

Minimum Qualifications:
  • Degree or vocational qualification in a Life Science, preferably Microbiology, or exceptional candidate without a degree.
  • Substantial experience in study design, coordination and management.
  • Significant experience of working with In Vitro Diagnostic Regulation requirements.
  • And/or
  • Experience of working with ISO 16140 and/or AOAC validation processes.
  • Detailed knowledge of microbiology test standards (e.g. ISO, FDA BAM, USDA).
  • Advanced mastery in working as part of a cross-functional team and on their own initiative, well organised and with ability to manage their own time amongst multiple projects.
  • Excellent communication skills both written and oral.
  • Comprehensive working knowledge of Microsoft Word, Excel, PowerPoint and Project.

Preferred Qualifications:
  • Knowledge and experience of customer requirements in relation to food microbiology laboratory processes and accreditation requirements.
  • Experience in the application of statistics to data.
  • Comprehensive knowledge of EU and US food safety legislation.
  • Demonstrably strong commercial awareness and customer focused mentality.
  • Thorough knowledge of internal business processes would be an advantage.

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