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Senior Scientist – Immunodiagnostics Further Information

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80,000 - 150,000 $ per annum + + Benefits

REF

EL-040119-SS

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Senior Scientist – Immunodiagnostics

Cartwright James is currently representing a Point of Care Immunodaignostic company that offers a portfolio of tests for the diagnosis of Infectious Diseases and Cardiac Function. This company is currently in a huge growth phase, expanding the test menu and the markets in which they operate.

My client is seeking a highly motivated and dynamic Senior Scientist who has the skills to develop assays to be translated into new Point of Care immunoassay products. This candidate will design, execute and document a series of experiments products, processes, operations, and investigations in order to develop a protein diagnostic test to be commercialised.

Thriving working in a fast growing and interdisciplinary team, the candidate will be tasked with:

  • Leading projects throughout development and launch of ELISAs, Immunoassays and other Multiplexed Assays, implementing design control processes throughout each phase of development (planning, process development, verification, validation and review).
  •  Leading the team in the generation of design history files to obtain and maintain FDA/CE-IVD and IOS compliance.
  • Critically reviewing experiment protocol, data and analysis, initiating corrective actions by employing DOE, SPC and continuous improvement techniques.
  • Planning and executing clinical and non-clinical studies, evaluating results and determining subsequent project course of action.
  •  Reducing process variation by identifying factors of process variation, improving process capability.
  • Acting as the Infectious Disease SME, providing technical advice and keeping a pulse on relevant marketing, scientific and patent literature.

Requirements:

  • PhD in Biochemistry or similar preferred
  • >5 years’ proven track record developing Immunodiagnostic products.
  • Proven knowledge of CE-IVD regulations, with experience of FDA 510k submissions alongside this as a strong preference.
  • Working knowledge of ELISA, ELISPOT, flow cytometry, cell culture and assays, and statistical methods a distinct advantage.
  • Training in Six Sigma desirable.

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-040119-SS

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