Lead Assay Scientist (IVD)
Our Client, a startup IVD company are searching for a talented Lead Assay Scientist to help bring a cutting edge diagnostic system through design, development, verification, validation, clinical trials, and regulatory approval.
The ideal candidate will be comfortable working with uncertainty, enjoys solving problems collaboratively, and someone who can help our Client bring a game-changing platform technology to market. The successful candidate will be commercially minded and product-focused, innovative, and collaborative with a proven track record of success from conceptualisation through implementation.
- Designing, executing and analysing experiments in the laboratory within a team setting .
- Utilising a range of methods/assays/techniques in support of all activities associated with assigned projects aimed to ensure project targets are met.
- Ensuring the efficient and successful delivery of project work packages to agreed timelines, actively reporting deviations/issues, making updates to timelines and conveying this information clearly and concisely in a timely manner to the CSO and wider Leadership Team where required.
- Ensuring team compliance is maintained by championing the adherence to Novuss Quality Management System, ISO13485 standards, Health and Safety and GLP requirements
- Overseeing, mentoring and providing guidance and training to new/junior staff members, contributing to their professional development.
- Authoring, executing, documenting and reviewing technical plans, data reports, process flows and Standard Operating Procedures (SOPs)
- Maintaining consumable inventory levels within the laboratory and ensuring that equipment maintenance and calibration is performed in line with approved procedures.
- Ensuring own work and that of supervised staff meets regulatory & quality requirements.
- Representing the department in internal and external audits where appropriate
- Supporting external relationship development (e.g., grant applications, KOLs and partners)
- Supporting the identification of commercially and technically useful solutions for development
- Degree in a life science such as microbiology, biochemistry, molecular biology or equivalent.
- Minimum of 5 years of relevant industrial hands-on experience with assay development and techniques
- Experience developing and documenting product development work under design control and QMS, policies, and procedures in compliance with FDA, GLP, GMP, ISO 13485 and SOPs
- Direct involvement in the management of a diagnostic device from concept through to product sale
- Previous experience with regulatory approval processes for in vitro diagnostic devices (US, EU, other)
For further information on this role in please contact Mark Wilson on 0860449473 or email email@example.com
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