R&D Technical Lead

Company Overview

At FlexMedical Solutions (FMS), we help our customers bring their ideas to life and create a healthier tomorrow, by providing contract design, development, and manufacturing services to medical device OEMs.

We focus on the disposable component of diagnostic tests and have significant expertise with point of care (POC) in vitro diagnostics (IVD).  We provide full assay development services and have impressive in-house manufacturing capabilities, ranging from screen printing and laser ablation of electrodes for biosensors to final device assembly, including the formulation and deposition of chemistries.

Our modern facilities are based in Livingston, central Scotland, less than 20 minutes from Edinburgh and 40 minutes from Glasgow.  With a healthy mixture of UK and international clients, we are a forward-looking organisation with an exciting future.

 

Role Description

As a qualified scientist you will bring hands-on technical expertise to the company and will have previously managed complex technical projects in IVD.  Having gained extensive experience in the laboratory, you will understand how to develop commercial in-vitro diagnostics and are likely to have specific experience in electrochemical and other common assay detection methods.  With an interest in how products work chemically, fluidically, and mechanically it is expected that your work experience goes beyond the lab, and you will operate comfortably as both scientist and project manager, managing and supporting your team to achieve successful and timely outcomes.

As a contract business, we work on multiple projects simultaneously.  This brings a lot of variety and requires people who are both willing and able to develop new products and processes in unison with our design control process.  Working for a scaling organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.  Your time will be spent working on customer specific contracts (developing and manufacturing diagnostic products on their behalf) and working on internal development programmes.

 

Key Responsibilities

Reporting to the CSO, 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 programme.
• Design reagents and sensors capable of reliable and safe measurement of analytes.
• Development of enzymatic, colorimetric, and immune assay formats.
• 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 both in the lab and the 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.
• 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.
• 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 required

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 IVD
• 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
• Have experience in electrochemical methods and/or 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 potentiostats and spectrophotometers
• Experience of statistical analysis on data, and presenting high level summaries for communication
• Understand Good Manufacturing and Good Laboratory Practices (GxP)
• Experience of working to ISO13485 and 21 CFR Part 820 and familiarity with product and process validation.

Desirable

• Experience in developing electrochemical point of care products
• 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.
• Managed 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.

 

Environment & Culture

FlexMedical Solutions is an evolving, scaling organisation operating in a highly regulated industry.  The company is enjoying growth through success and is working on several leading edge projects with particularly exciting customers.

It is a changing environment that requires you to be very flexible, resilient, and willing to learn and grow with the company.  It is essential that you communicate with your colleagues and contribute to the company’s success. As a provider of sub-contract services, working for FlexMedical Solutions will bring a lot of variety and excitement.  Initiative will be rewarded, and personal development is a given.