Scientist II

The Scientist II is the scientific/technical lead of IVD development projects, i.e.

1. Design of innovative technology building blocks
2. Technical feasibility studies involving prototyping
3. New assay development projects following design control and Biocartis QMS
4. Scope expansion development projects (including rest-of-the-world market expansion and follow-on Companion Diagnostics (CDx) projects)
5. New assay development projects for the life cycle Menu “product portfolio”, Flex “on demand customer portfolio” and Partner “CDx and content” (Content partner projects include porting of third-party assays onto the Idylla^TM platform; or R&D project externalised to a third party as contract development strategy)
6. Continuous improvement projects for IVD development
7. On market product support projects

Accountabilities

• Scientific/technical lead of cross-functional development teams, based on an in-depth knowledge of the Idylla^TM platform and associated technologies and underlying biological/biochemical mechanisms knowledge;
• Leading the design process trajectory following internal processes integrated into the global process workflow for IVD development;
• Translation of project charter into anticipated design specification;
• 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 (RC) i.e, QMS, IVDR and/or FDA and any other applicable RC;
• On-time delivery of design output, i.e. molecular biological and biochemical design choices and applicable documentation necessary to complete the Design History File (DHF);
• Support development project of one of the life cycles (incl. Menu “product portfolio”, Flex “on demand customer portfolio” and Partner “CDx and content”);
• Implement risk mitigation processes (dFMEA)
• Submission of scientific abstracts, manuscripts, grants and patent applications;
• Continuous improvement of Biocartis’ design and development processes in terms of quality and/or (cost-)efficiency;
• Maintaining scientific knowledge: Keeping up to date with relevant scientific and technical developments.

Profile requirements

• PhD in science- or technology-related study domain, with 1-3 years in industry, with profound expertise in molecular biology, preferably applied to the field of oncology (infectious disease also relevant and NGS considered as a plus) or
• Master in science- or technology-related study domain with 4+ years in biotech industry, with molecular biology applications preferably in the field of oncology (infectious disease also relevant, NGS considered as a plus)
• Or equivalent though relevant experience
• Profound research experience in molecular biology (focus on nucleic acids extraction, (RT-(q)PCR design and optimization)
• Scientifically sound way of working (hypothesis-driven testing and experimental set-up)
• Strong problem solving skills
• Good scientific communication skills (presenting and writing, including abstracts, publications, grants, work instructions)
• Knowledge of IVD development, including the regulatory context (IVDR and FDA)
• Knowledge of Oncological Pathology
• Applied knowledge of statistics (principles & tools)
• Strategic thinking – Understands and applies Biocartis vision and strategy and aligns actions with it
• Analytical thinking – Gathers information from varied sources, analyzes data in a critical way using common sense and logical thinking
• Planning and Organization – Time & priority management: plans activities effectively with respect for priorities and deadlines
• Resilience – Continues to perform effectively under time pressure and in the face of disappointment, adversity and opposition
• Adaptability to change – Adapting to change: accepts and implements change and adapts, even in difficult situations
• Communicates with persuasion – presents, explains and defends a complex message in a clear and concise way and persuades different stakeholders
• Legislation and regulation:
  • Awareness of intellectual property and its implications
  • Applied knowledge of IVDR and/or FDA compliance
  • Applied knowledge of GLP
• PC skills:
  • Knowledge of relevant scientific databases, Bio-IT and statistical tools
  • Applied knowledge of MS Office (Word, Excel, Powerpoint), Outlook
• Languages:
  • Excellent English (written and spoken)
  • Any other language is an asset

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package besides attention to your Wellbeing and Flexibility due to our hybrid way of working (3 office days, 2 work from home days).