BBI exists to help our customers create advances that improve health and save lives. We are seeking a Senior Performance Evaluation Scientist to join our team. This is a fixed-term, full-time position based at our site in Crumlin. Join our team: advancing health, together.
The Role
This is a 12-month fixed-term contract role focused on completing the IVDR performance evaluation requirements for the BBI autoimmune ELISA product portfolio. The Senior Performance Evaluation Scientist will work closely with the Regulatory team to plan and execute analytical and clinical performance studies, prepare protocols and reports, analyse data, and ensure all evidence meets IVDR and CLSI guideline expectations. The role includes completing laboratory testing to defined timelines, troubleshooting technical issues, and preparing audit-ready documentation for Notified Body submission.
This position is suited to an experienced scientist who can work independently and take ownership of performance evaluation activities with minimal supervision. Prior experience contributing to IVDR performance evaluation documentation such as performance evaluation protocols and performance evaluation reports, analytical/clinical performance studies and scientific validity assessments is desirable but not essential.
In this role your responsibilities will include:
1. Ability to bring specialist technical knowledge for autoimmune ELISA products into the team.
2. Independently plan, perform and document laboratory work to required standards, including maintaining laboratory cleanliness, equipment, and safety compliance.
3. Troubleshoot technical issues, support CAPA investigations where required, and ensure all documentation meets ISO 13485 QMS and traceability requirements.
4. Ability to plan, design, execute and report analytical and clinical performance studies for performance evaluation.
5. Prepare method comparison studies, stability studies, verification and validation studies and associated reports for internal and external review.
6. Perform in-depth statistical analysis (e.g., precision, LoD/LoQ, linearity, sensitivity, specificity) and present conclusions clearly to regulatory and technical stakeholders to substantiate product claims.
7. Complete Performance Evaluation Plans (PEPs) and Performance Evaluation Reports (PERs) for all BBI ELISA products for submission to notified body under IVDR.
8. Support regulatory team with updates to product claims and Instructions for Use (IFUs) based on new analytical and clinical evidence.
9. Ability to support regulatory team with preparation of performance evaluation packages for submission to the Notified Body.
You should apply if:
10. Strong understanding of immunoassays, particularly ELISA, with experience in assay verification, validation, and troubleshooting.
11. Familiarity with IVD regulatory requirements (IVDD, IVDR 2017/746) and applicable guidance such as and CLSI guidelines.
12. Experience working within diagnostic Quality Management Systems (ISO 13485, 21 CFR Part 820).
13. Proficient in data analysis, including use of statistical tools (e.g. R, JMP, GraphPad Prism).
14. Experience preparing technical or scientific reports in a regulated environment.
Our Recruitment Process
If this role sounds like it’s for you, click ‘apply’ today. Once we’ve received your application, a member of our recruitment team will be in touch to arrange a call. On this call, we’ll be able to tell you a lot more about working here at BBI Solutions, how ‘a day in the life’ of this position looks and discuss the next stages of the recruitment process.
If you are an internal employee applying for this vacancy you and your manager are required to complete an internal transfer form. This needs to be completed in full and attached to your application along with your CV and cover letter.
As part of career development and succession planning internal applicants will receive priority consideration initially, please ensure that you apply within the initial two-week period to support this.
Why Choose BBI
We are committed to promoting and protecting the physical, financial, and emotional well-being of all our employees. With our employees focused on others, we’re focused on them. That’s why, at BBI, we’re dedicated to providing our employees with access to global resources and site-specific benefits that support their health and wellbeing.
15. Competitive Salary with Yearly Salary Reviews
16. 5% Contributory Pension Scheme
17. Life Assurance (4x Annual Salary)
18. Private Health Care Scheme – including dental
19. Global Employee Wellbeing Programme
20. Reward and Recognition Programme
21. Commitment to Career Development
22. Generous Annual Leave Package
23. Cycle to Work Scheme
24. Refer A Friend Scheme
25. Subsidised Canteen
26. Free Onsite Parking
27. Electrical Vehicle Lease Scheme
28. Electrical Charging Points
29. State of the Art Facilities – Certified Centres of Excellence
We’re also focused on development, creating an environment that allows our employees to nurture their talent and empowers you to make a difference. This is achieved by providing our employees with access to learning opportunities to help achieve personal career goals.
About BBI
For more than 70 years, we’ve been perfecting reagents, both native and recombinant, to help IVD and life-science teams turn breakthrough ideas into reliable, life-saving advances.
Great products are only the start. From troubleshooting tricky performance issues and customising reagents to meeting new regulatory standards, our scientists work to clear obstacles and accelerate progress. That’s why we continue to invest millions in new recombinant capabilities that help create diagnostics that improve health and save lives - in a more ethical and sustainable way than ever before.
Equal Opportunities
BBI are an equal opportunity employer and believe in fair treatment for all candidates. Qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
We ask that all applicants complete an equal opportunity monitoring form on a voluntary basis, with all submissions remaining anonymous. The information on the form will be used for monitoring purposes only and will not be used in any decision affecting you.
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Please note that we reserve the right to close this advertisement at any time upon securing a suitable candidate.