Jobs in life sciences

Senior scientist (IVD development)

Ref. SRSC
Function: The senior scientist is the scientific/technical lead of IVD development projects.
Location: Mechelen

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:

Purpose of the position

The senior scientist is the scientific/technical lead of IVD development projects, i.e.

  • design of innovative technology building blocks
  • technical feasibility studies involving prototyping
  • new assay development projects
  • scope expansion development projects (including USA market expansion and CDx projects)
  • partner projects involving the porting of third-party assays onto the company’s platform 

The senior scientist reports to the Manager Design Team. 

Accountabilities

  • Scientific/technical lead of (multiple) cross-functional development teams, based on an in-depth knowledge of the company’s platform and associated technologies;
  • Translation of user needs into (i) design input (product requirements) and (ii) design and development strategy, taking into account the scientific/clinical context, technological constraints and regulatory compliance (IVDR and/or FDA);
  • On-time delivery of design output (molecular biological and biochemical designs and development documentation);
  • Support of business development (product portfolio strategy and partner collaborations);
  • Submission of scientific abstracts, manuscripts, grants and patent applications;
  • Continuous improvement of the company’s design and development processes in terms of quality and/or (cost-)efficiency;

On-boarding/coaching of new/junior design team members.

Requested competences and skills:

  • Strong background in molecular biology, design and IVD
  • PhD in science- or technology-related study domain with profound expertise in molecular biology (preferably in the field of oncology) OR a master’s degree in science- or technology-related study domain with at least 4 years of industrial research experience in molecular biology (preferably in the field of oncology);
  • Experience with IVD development, including in-depth knowledge of the regulatory context (IVDR and FDA), is mandatory;
  • Experience with defining and optimizing IVD process infrastructure is mandatory;
  • Profound research experience in molecular biology (focus on nucleic acids, (RT-)(q)PCR design and optimization);
  • Scientifically sound way of working (hypothesis-driven testing and experimental set-up);
  • Excellent scientific communication skills (presenting and writing, including abstracts, publications, grants, work instructions);
  • Experience in the field of Oncological Pathology;
  • Knowledge of relevant scientific databases, Bio-IT and statistical tools;
  • Awareness of intellectual property and its implications;
  • Strong communicator and planner: proven experience with steering cross-functional teams and coaching junior scientists is mandatory;
  • Highly driven: reach ambitious goals in a fast-paced, dynamic environment;
  • Passionate about science and technology: transform cancer patient management;
  • Language skills: Excellent English (written and spoken), any other European language is considered an asset;
  • PC skills: MS Office.
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