Research And Development Manager

1 month ago


Livingston West Lothian, United Kingdom FlexMedical Solutions Full time

Job Description

Are you looking to join an innovative, growing, Scottish SME?

FlexMedical Solutions provide contract design, development and manufacturing services to medical device OEM's, with a key focus on POC IVD from their site in Livingston.

The business is going through a phase of exciting expansion and are seeking a manager to join the tight-knit R&D department to lead scientific teams on IVD development projects from concept to manufacture.

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 significant experience in the laboratory, you will understand how to develop commercial in-vitro diagnostics and are likely to have some specific experience in electrochemical and other common assay detection methods.

Your time will be spent working on some of our customer specific contracts (developing and manufacturing diagnostic products on their behalf), and also working on internal development programmes.

Due to the size of the business, this is a senior role for an individual who will thrive in a scale-up environment and looking for the opportunity to be a recognised contributor in the growth of the operation.

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.
  • 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 and Experience

  • 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
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