Industrialisation Expert

20/04/20

Location

Generaal de Wittelaan 11B Mechelen Belgium

Function type

R&D – Industrialisation

Vacancy

About Biocartis

Biocartis is an innovative molecular diagnostics company committed to revolutionize molecular testing with its unique proprietary IdyllaTM platform. We provide next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and the healthcare industry, with a focus on oncology.
Biocartis’ proprietary molecular diagnostics (MDx) IdyllaTM platform is a fully automated sample-to-result, real-time PCR system that offers accurate, highly reliable molecular information from virtually any biological sample, in virtually any setting, allowing fast and effective treatment selection and treatment progress monitoring.
Biocartis employs over 450 people and is headquartered in Mechelen, Belgium.

Industrialisation Expert

The Industrialisation Expert is responsible for:

  • the development and verification of cartridge (CAR) manufacturing processes for new developed products

  • the QC method development and validation of assay-specific test methods for new developed products

  • the stability strategy for new developed products

  • the transfer of processes and methods to the operational teams (New Product Introduction (NPI) & QC Operations).

Accountabilities

  • Oversees the development of CAR manufacturing processes, QC method development & stability activities and their delivery according to required technical requirements, quality levels, project plan and budget

  • Supports, plans and monitors progress of the assigned development projects

  • Technical responsibility on the development of the assay specific CAR manufacturing process steps (e.g. liquid dispensing process qualification, drying process parameters and limits, collection and analysis of process data, in process controls)

    • Plans, carries out, and supervises process trials

    • Verifies for the assay specific process steps if the process parameter settings lead to a stable and capable manufacturing process

    • Efficient knowledge transfer of the assay specific process steps to Process validation

  • Technical responsibility on QC Method Development & Stability during all phases of the Assay Development Projects

    • Proposes, develops and validates QC methods, makes recommendations for the performance of  experiments in QC areas, including equipment, summarizes analyses and interprets data in order to draw conclusions

    • Develops strategy for stability testing, QC test panels and implementation of test methods including transfer to and training of QC operations

  • Ensures the proper and timely preparation of protocols, reports, technical reviews, risk analysis and other documents

  • Ensures compliance with national and international (CE, FDA) regulatory requirements and other applicable guidelines. Oversees quality reporting and documentation related to the development activities

  • Presents own work at in-house forums and at outside professional meetings.

  • Acts as the subject matter expert for Industrialization in project core teams

  • Participates in discussions at assay development and inter-departmental meetings in order to share information, knowledge, ideas, process improvements and judgment to help establish efficient industrialization directions

  • Participates in/Leads troubleshooting activities for established test methods/processes

  • Continuously assesses development processes and identifies improvement opportunities

  • Coaches, mentors, grows and motivates junior team members and/or lab technicians, and delegates work assignments effectively

Profile requirements

  • Strong attention to detail and quality driven

  • Excellent oral communication and technical writing skills

  • Ability to manage multiple priorities

  • Flexible mindset

  • Ability to execute effective decision-making and planning, both as an individual and as part of a team and planning

  • Cross-functional team player with well-developed interpersonal skills and able to work independently

  • Problem identification, analysis and solving skills

  • Scientific integrity

  • Business acumen

  • Result oriented

  • Likes to coach and provide direction

  • Languages: advanced knowledge, orally and in writing of Dutch and English

  • PC skills: MS Office

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.

Interested? Please apply via HR@biocartis.com

Job application