R&D Manager

Search Consultancy
17 Sep 2019
11 Oct 2019
Contract Type
Full Time

Our client is developing revolutionary medical devices and technologies for the Diagnostic sector. Seeking an experienced R&D Manager.

Role Description

  • You will lead a project team to develop and deliver diagnostic assays to meet the product requirements for launch in line with the company's goals and timelines.
  • You will be responsible for the technical leadership of the project as well as the continuous growth and development of the projects scientific team.

Key roles and Responsibilities

  • Leading the development of individual assays from concept through Design Freeze and Transfer to Production to Launch following our Design and Development process incorporating Design for Manufacture(DFM) approach.
  • Run the daily cross functional project meetings incorporating Voice of Customer.
  • Managing internal and external partners to support the assay development.
  • Developing a robust assay system through product characterisation, risk management and testing to failure.
  • Ensuring that the developed assay and its components are capable of meeting the required performance, stability and cost requirements for the assay platform.
  • Ensuring Design Control procedures are adhered to and generate project deliverables such as:
    • Design & Development Plans
    • Product Requirement Documents
    • Design History Summary report
    • Pre Validation and Verification Plan
  • Ensuring GDP, GLP and GMP standards are maintained.

Essential skills

  • Degree qualified in a relevant scientific discipline
  • Detailed knowledge and understanding of factors which drive Immunoassay performance (such as stability, precision, sensitivity, accuracy)
  • Experienced in root cause analysis and technical problem solving.
  • Experience of working to ISO 13485 or FDA 21CFR, part 820 (or similar)
  • Experience and knowledge of requirements to launch an in-vitro diagnostic product (validation and verification, FMEA, control solutions, on-board controls, etc.)
  • Experience of leading multiple R&D projects, from proof of concept to product launch.
  • Experience of leading technical and project teams of varying sizes

Desirable skills

  • Experience of using particle-based immunoassays.
  • Experience with fluorescent technology
  • Experience of optimising formulations for drying reagents for use in POC immunoassays
  • Experience with launching IVD products in multiple geographies (US, EMEA, China)

If you have any questions, want to know more or wish to apply, please contact me.

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.