Generaal de Wittelaan 11B Mechelen Belgium
R&D – Industrialisation
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.
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).
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
Strong attention to detail and quality driven
Excellent oral communication and technical writing skills
Ability to manage multiple priorities
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
Likes to coach and provide direction
Languages: advanced knowledge, orally and in writing of Dutch and English
PC skills: MS Office
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