Job Title: Product Evaluation Specialist
Position Location: Basingstoke, Hampshire UK
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.
Brief role summary:
The Product Evaluation Specialist will perform and/or manage studies of new and existing Microbiology Division (MBD) products in the clinical, food safety and pharmaceutical sectors.
- Compile study protocols for studies of MBD products in accordance with departmental SOPs and other supporting documentation to reflect the requirements of the business.
- Design coordinate, manage and review studies as determined by manager 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.
- 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 validation and certification of food safety products (e.g. via 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.
- Analyse study data and prepare study reports.
- Present study findings to the business (both written and verbally) where required.
- Assist in maximising value from entire Product Evaluation Team budget.
- Attend and present work at scientific events.
- Carry out any further tasks that are reasonably requested by Manager.
- Degree or vocational qualification in a Life Science, preferably Microbiology, or exceptional candidate without a degree.
- Knowledge of microbiology test standards (e.g. ISO, FDA BAM, USDA) and AFNOR/AOAC-RI validation processes along with experience of working practices preferred by validation bodies.
- Must have the ability to work as part of a cross-functional team and on their own initiative, be well organised and have good time management skills.
- Excellent communication skills both written and oral.
- Comprehensive working knowledge of Microsoft Word, Excel, PowerPoint and Project.
- Knowledge of EU and US food safety legislation and In Vitro Diagnostic regulation requirement.
- Experience in the application of statistics to data.
- Aptitude for practical laboratory work.
- Thorough knowledge of internal business processes would be an advantage.
For further information please contact firstname.lastname@example.org