R&D Technical Lead

All applications to come through Alan Kane at Kleboe Jardine - ak@kleboejardine.com
We are currently hiring for an R&D Technical Lead position here on a permanent basis.
As a significantly experienced scientist you will bring hands-on technical, and strategic expertise to the company.
Having demonstrated superior skill in the lab through multiple programmes, you will be skilled in the development of in-vitro diagnostics and will have specific experience in reagent development for common assay detection methods such as e-chem, fluorescence, chemiluminescence. You will be engaged in customer specific contracts, developing and producing diagnostic products on their behalf, in addition to internal development activity.
As a contract business, we work on numerous projects with several clients simultaneously. This brings a lot of variety and requires people who are both willing and capable of working on concurrent multiple projects.
Working for a scaling organisation will provide you with a fantastic opportunity to make your mark and implement your ideas, helping to steer the company’s technical direction.
Key Responsibilities
Reporting to the Technical Lead/CTO, you will: -

• Manage a team of scientists to successfully achieve project outcomes efficiently and within timescale.
• Manage project staff to rapidly identify, root cause and mitigate technical problems in complex biosensor programmes.
• Design reagents and sensors capable of reliable and safe measurement of analytes.
• Development of electrochemical, enzymatic, colorimetric, and immune assays.
• Quickly understand client’s biochemical pathways and be able to critique and plan improvement approach.
• Collaborate with engineering to ensure electrodes and fluidic cells can deliver sample and reading output from biochemical assays across a range of detection systems (echem, fluorescence, etc).
• Demonstrate effective lab craft, operating successfully in both the lab and office environment.
• Develop and execute electrochemical methods for external customer requirements, and internal development programmes.
• Drive experimental design to make swift robust technical design decisions.
• Produce all necessary documentation required for product technical files (design history files).
• Provide impactful and diligent updates for internal and external stakeholders.
• Work with clients to ensure robust and product focused technical work is scheduled and executed effectively.
• Author, oversee, and execute protocols and reports (R&D, Verification, Validation, SOPs).
• Develop product and process technical documents to successfully introduce new products and processes into manufacturing.
• Communicate effectively with sub-contractors, suppliers, and customers.
• Provide scientific and project direction to team members, ensuring problems are quickly resolved and designs evolved to improve performance.
• Provide scientific input into product and process designs, ensuring optimal performance and client satisfaction.
• Produce characterisation reports for customer products and development reports for internal programmes aligned to the Quality Management System.
• Drive projects and teams with a daily mindset.

Skills, Knowledge and Experience
Essential

• Qualified to degree level as a minimum in a relevant scientific subject (in lieu of academic qualification, we will consider candidates with significant and demonstrable experience in the IVD industry)
• Experience of working in a similar role within the IVD industry
• Experience of managing staff to produce high performing teams, including undertaking recruitment, actively developing team members, conducting appraisals, and managing performance and conduct matters
• Experienced in designing reagents and formulations from first principles
• Experience in electrochemical assay development and other detection systems in IVD
• Have experience in IVD product development and validation, and the complete design control lifecycle
• Be competent using laboratory test apparatus such as potentiostats and spectrophotometers
• Experience of statistical analysis on data, and presenting high level communication summaries
• Understand Good Laboratory and Good Manufacturing Practices (GxP)
• Experience of working to ISO13485 and 21 CFR Part 820 and familiarity with product and process validation.

Desirable

• Experience of launching point of care platforms
• Understand Design for Manufacture (DFM) methodology
• Experienced using statistical tools such as Minitab and understands Design of Experiments approach to optimisation
• Experienced in reagent chemistry as applied in IVD products
• Experienced in surface chemistry: modification and analysis
• Management of a commercial IVD product development through to launch
• A Green or Black Belt qualification in six sigma / process excellence
• Experience of operating in a project management environment where “Daily Management” is the norm.

Visa Sponsorship is available for candidates with the right skills, particularly skilled in Electrochemistry
Apply above or reach out to me at ak@kleboejardine.com for a confidential discussion about the opportunity