The 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 following design control and Biocartis QMS
* Scope expansion development projects (including rest-of-the-world market expansion and follow-on Companion Diagnostics (CDx) projects)
* 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 IdyllaTM platform; or R&D project externalised to a third party as contract development strategy)
* Continuous improvement projects for IVD development
* On market product support projects
Accountabilities
* Scientific/technical lead of cross-functional development teams, based on an in-depth knowledge of the IdyllaTM 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).