JOB DETAILS

Senior Scientist – Colorado Further Information

Job Details

Location

Colorado

Region

Position

Salary

100,000 - 150,000 $ per annum + + stock

REF

EL-051218-SSC

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Senior Scientist – Colorado

Cartwright James is currently working with an innovative Point of Care Immunodiagnostic company with a large portfolio of Immunoassays for the diagnosis of Infectious Disease. As the company expands its R&D activities, it is seeking a Senior Scientist to lead the development of a de-novo Immunodiagnostic product pipeline.

The candidate should have a proven track-record in the development and CE-IVD/FDA launch of Immunodiagnostic products. As an expert in Immunoassay development, the Senior Scientist will lead from the front, providing hands-on leadership throughout the managing of clinical studies, improving of assay validation and the development and launch of de-novo Immunoassays.

Responsibilities include:

  • Leading projects throughout development and launch of Immunoassays and other Multiplexed Assays, implementing design control processes throughout each phase of development (planning, process development, verification, validation and review).
  • Critically reviewing experiment protocol, data and analysis, initiating corrective actions as appropriate.
  • Designing clinical study protocol and managing clinical studies for regulatory submissions.
  • Leading the R&D team in the generation of technical files for product registration throughout CE-IVD and FDA validation.
  • Improving assay validation and method transfer protocol by employing DOE, SPC and continuous improvement techniques.
  • Acting as the Immunoassay SME, providing technical guidance throughout product development.
  • Guiding the risk management process.
  • Reducing process variation by identifying factors of process variation, improving process capability.

Requirements:

  • >5 years’ Immunodiagnostic product development experience.
  • Proven knowledge of CE-IVD regulations, with experience of FDA 510k submissions alongside this as a strong preference.
  • Proven track-record of launching IVD devices and/or immunoassays to CE-IVD and FDA markets.
  • Proven knowledge of experimental design and data analysis.
  • Strong literature search and analytical skills are essential.
  • Lean Six Sigma Green or Black Belt preferred.

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-051218-SSC

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