80,000 - 110,000 € per annum + + Benefits
Cartwright James is currently working with an innovative in-vitro Diagnostics with a successful portfolio of Infectious Disease Molecular Diagnostics. This company is looking for a motivated Head of R&D to lead the development and launch of a pipeline of de-novo Real Time PCR Assays.
With a proven track-record in the development and launch of Molecular Diagnostic Products, the Head of R&D will lead an expanding international team in the evaluating of new methods and the development and validation of Multiplex Real Time PCR procedures and products. As a motivated leader, the individual will be responsible for managing multiple simultaneous projects in a dynamic laboratory environment, driving novel product development and existing product improvement.
*Directly lead an expanding Assay Development Group, currently comprised of around 15 individuals with plans to double in size in the near future.
*Develop and optimize multiplex Real-time PCR assays for diagnostic products in line with ISO13485 standards.
*Determine testing, verification and validation strategies for new assays and technology platforms, leading the development of plans and summary reports in line with Quality Systems requirements.
*Leading the projection of capacity, costs, personnel, equipment, reagents and time requirements for test procedures and development and implementation of technology platforms.
*Lead product transfer activities, coordinating with Operations to finalize training recommendations and train staff on new test procedures as needed.
*Interface with external stakeholders, determining requirements for special projects and developing experimental approaches to expand company offering.
*Critically review new technology on an ongoing basis, alongside maintaining a strong scientific presence.
*>8 years’ molecular biology laboratory experience in a commercial setting, with Real Time PCR product development experience essential.
*>5 years’ direct leadership experience, managing high-performing teams and multiple projects simultaneously.
*Proven track-record in FDA/CE-IVD molecular product launch, with strong knowledge of ISO13485 Quality Systems.
*PhD in Biology or related field preferable.
*Fluent written and spoken English essential, with other European languages as an advantage.
*Proficient throughout both Microsoft and basic statistical analysis.
*Willingness to travel.
Cartwright James is a global executive search and selection company based in the UK, providing expert knowledge and bespoke services in the international Chemicals, Medical and Scientific markets. We receive a vast volume of applications for each position, therefore it takes time to assess each candidate. We will be in touch if the candidates experience matches the job requirements.
Job Reference: EL-HRD-091118