R&D Verification & Validation Specialist
R&D Verification & Validation Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
About ANGLE:
ANGLE is a world-leading liquid biopsy company commercialising a patent protected platform technology that can capture rare circulating tumour cells (CTCs) from blood in a minimally invasive way for downstream analysis.
ANGLEs Parsortix system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood. Parsortix technology comprises a microfluidic device that captures CTCs from blood based on their size and compressibility. CTCs are cancer cells that have detached from the primary tumour and entered the blood circulation and they play a critical role in initiating metastasis. Once harvested the CTCs can be comprehensively analysed to provide a wealth of information about the patients tumour advancing cancer research and potentially personalized medicine. This technology has the potential to deliver profound improvements in clinical and health economic outcomes.
ANGLE has established a CTC harvest and analysis service from our UK-based Clinical Laboratory based in Guildford for customers worldwide. In alignment with company priorities we plan to rapidly expand our services to include molecular profiling of CTCs and ctDNA using digital PCR and NGS to add to our image-based assays.
Join our Team:
This is an exciting time at ANGLE and ourteam inGuildfordare looking for anR&D Verification and Validation Specialist. The R&D Verification and Validation Specialist will actively contribute to a cross-disciplinary assay/product development team.
The R&D Verification and Validation Specialist manages the design and execution of V&V activities throughout all phases of the new product development process in the R&D team. This includes the design of test methods and test strategies development and execution of formal protocols analysis and interpretation of results and communication of results and their impact through written reports design reviews and interactive discussions.
The R&D V&V Specialist will work in a matrix environment interacting with stakeholders across all areas of the business to ensure cohesion effective communication and problem solving.
At ANGLE we foster a dynamic entrepreneurial approach to translating leading-edge translational research into clinical diagnostics. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas.
We are always in search of potential employees who share our vision and want to make a difference today. In your submission please describe your background and what you can bring to our team along with attaching your resume.
Principal Accountabilities:
- Design develop and execute V&V plans protocols and reports for instruments systems assays and software in the R&D laboratory.
Collaborate cross-functionally with R&D QA Regulatory Affairs and Engineering teams to define user requirements and functional specifications. - Conduct verification testing to confirm systems and processes meet defined input requirements.
- Execute validation testing to ensure solutions fulfil intended use and performance criteria.
- Lead and execute technology transfer scale-up and process optimization to meet critical project deadlines.
- Perform risk assessments including FMEA or equivalent methods to guide V&V planning and scope.
- Support the implementation of quality and regulatory compliance processes related to design control product development and change management.
- Document and manage deviations CAPAs and change controls related to V&V activities.
- Contribute to regulatory submissions by preparing or reviewing V&V-related documentation.
Qualifications Experience Knowledge and Attributes:
- Bachelors degree in biotechnology Life Sciences or related field.
- 3 years of experience in V&V roles within biotech medical device or pharmaceutical industries.
- Strong understanding of V&V methodologies design controls and regulatory frameworks such as FDA QSR ISO 13485 ISO15189 GMP and ICH Q8/Q9.
- Strong experience performing statistical analysis (including calculation of sample sizes and/or estimation of statistical power) and interpreting experimental results
- Proven experience in writing and executing test protocols and reports.
- Strong analytical skills and attention to detail with excellent documentation practices.
- Experience with assay or diagnostic system validation in an R&D setting.
- Experience working within a regulated medical device industry with knowledge or experience in FDA submissions
- Familiar with accreditation and guiding agencies for the clinical laboratory including CAP CLIA and CLSI including experience in audits conducted by accrediting bodies
Preferred:
- Familiarity with software/system validation (e.g. 21 CFR Part 11 compliance).
Job Requirements:
Due to the nature of the role our requirement is for this position to be Guildford-based office hours five days per week.
As a member of our highly skilled team you will receive opportunities for training and development and a competitive benefits package.
Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs.
Furthermore please be advised that if you submit an application to us for this position your application and personal details will be processed in accordance with ourData Privacy Notice for Job Candidates.
Important notice to Employment Businesses/ Agencies:
ANGLE does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact our ANGLE recruitment team to obtain prior written authorisation before referring any candidates. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ANGLE. ANGLE shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Required Experience:
Unclear Seniority
Employment Type
Full Time
