Senior Scientist

The Senior Scientist 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-up 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 (customer excellence).

Accountabilities

The role includes, but is not limited to, the following accountabilities:

• Scientific/technical lead of (multiple) cross-functional development teams, based on an in-depth knowledge of the Idylla^TM platform and associated technologies and of excellent 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 proects of one of the different life cycles (incl. Menu "product portfolio", Flex "on demand customer portfolio" and Partner "CDx and content";
• Implement risk mitigation processes (dFMDEA);
• 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;
• Supervising/coaching junior staff including Lab Technicians;
• Provide training related to design and technology across the different functional areas;
• Gatekeeping activities related to external communication;
• Maintaining specific knowledge : keeping up to date with relevant scientific and technical developments.

Profile requirements

• PhD in science- or technology-related study domain with 4+ years in industry, and 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 8+ years in biotech industry, with molecular biology applications preferably in the field of oncology (infectious disease also relevant, NGS considered a plus);

  OR

  Equivalent through relevant experience/training

• Profound research experience in molecular biology (focus on nucleic acids extration, (RT) (q)PCR design and optimisation;
• Scientifically sound way of working (hypothesis-driven testing and experimental set-up);
• Strong problem-solving skills;
• Excellent scientific communication skills (presenting and writing, including abstracts, publications, grants, work instructions);
• Knowledge of IVD development, including the regulatory context (IVDR, FDA);
• Knowledge of Oncological Pathology;
• Applied knowledge of statistics (principles and tools);
• Applied knowledge of IP;
• Knowledge of relevant scientific databases, Bio-IT and statistical tools;
• Applied knowledge of MS Office (Word, Excel, PowerPoint), Outlook;
• Applied knowledge of LIMs (laboratory information system);
• Awareness of IVDR and/or FDA compliance;
• Applied knowledge of GLP;
• Analytical thinking : conducts ongoing in-depth analysis to anticipate potential problems and guides others in complex issues;
• Planning and organisation : Time & priority management : plans activities effectively with respect for priorities and deadlines;
• Communication and influencing : communicates with persuasion : presents, explains and defends a complex message in a clear and concise way and persuades different stakeholders:
• Resilience : maintains self-control, direction and effectiveness in high pressure situations;
• Coaching & Development : provides constructive feedback, takes an exemplary role towards learning, guiding and mentoring colleagues;
• Adaptability to change : accepts and implements change and adapts, even in difficult situations;
• Strategic thinking : understands and applies Biocartis vision and strategy and aligns actions with it.
• Language skills: excellent English (written and spoken), any other language is an asset.

Interested ?

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 an appropriate compensation package including a Flexible Income Plan. We invest in the development of our talents as well as in their wellbeing.