Jobs in life sciences

IVDR validation scientist

Ref. 212 - IVDRVS
Function: Join the design team and help out with the validation of IVDR product development projects.
Location: Offices in Mechelen, but remote work is strongly considered

The company:

The company is an innovative commercial stage molecular diagnostics(MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. The Company’s proprietary platform is a fully automated, real time system which offers accurate, highly-reliable molecular information from any biological sample in virtually any setting. It addresses the growing demand for personalized medicine by allowing fast and effective treatment selection and treatment progress monitoring.

The company is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest and largest growing segments of the US$5 billion MDx market which is expected to grow to approximately US$8 billion in 2018.

Job description:

  • Proposes validation strategies and plans for IVDR product development projects, based on product and regulatory requirements (US, CE, RoW).
  • Prepares and organizes (analytical) validation testing.
  • Writes tests plans, protocols and reports for (analytical) validation.
  • Collaborates with biostatistics to define statistically supported study designs.
  • Assists in preparation of verification and validation studies in collaboration with technical team.
  • Prepares and manages execution of Validation studies and  alpha trials with external and internal technical collaborators.
  • Collaborates in writing of technical documentation for end-user purposes.
  • Presents verification and validation studies on an internal and external level. 
  • Assists in preparation of regulatory (pre-) submissions.
  • Acts as a V&V expert in cross-functional meetings.
  • Identifies improvement opportunities and facilitates the implementation thereof.
  • Supports and trains external development parties in V&V related activities on the Idylla platform.

 

Requested competences and skills:

  • Preferably PhD in Pharmaceutical, Bioscience-engineering, Biomedical, (Bio)chemistry, Biotechnology, Biology sciences or equivalent through experience
  • 3-5  years industrial experience in a similar position is required
  • Scientific and technology background in molecular diagnostics
  • Experience with molecular detection techniques (real-time PCR and related)
  • Experience in IVD (development and validation studies)
  • Experience in validation of IVDs in a diagnostic industry setting
  • Strong knowledge of international regulatory standards (ISO, CLSI, FDA, IVDR) and GLP
  • Affinity with statistics
  • Strong communication and listening skills
  • Proactive attitude
  • Self-starter
  • Excellent interpersonal and team working skills
  • Well-developed organization, planning and prioritization skills
  • Excellent technical writing and documentation skills
  • Able to work under pressure and have a flexible approach
  • Thrives in a fast paced and changing environment
  • Excellent knowledge of English (written and spoken)
  • MS Office; eDC systems is an asset

 

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