The company is an innovative commercial stage molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. The Company’s proprietary platform is a fully automated, real time system which offers accurate, highly-reliable molecular information from any biological sample in virtually any setting. It addresses the growing demand for personalized medicine by allowing fast and effective treatment selection and treatment progress monitoring.
The company is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest and largest growing segments of the US$5 billion MDx market which is expected to grow to approximately US$8 billion in 2018.
As an Industrialisation Expert you are responsible for the development & verification of cartridge (CAR) manufacturing processes, the QC method development & validation of assay-specific test methods and the stability strategy for new developed products. You translate these processes to the operational teams.
• You oversee the development of cartridge manufacturing processes, QC method development & stability activities and their delivery according to required technical requirements, quality levels, project plan and budget.
• You are responsible for the follow-up of the progress of the assigned development projects (support, planning and monitoring).
• You have a technical responsibility on the development of the assay specific CAR manufacturing process steps
o For example: liquid dispensing process qualification, drying process parameters and limits, collection and analysis of process data, in process controls
o You plan, carry out, and supervise process trials
o You verify the assay specific process steps if the process parameter settings lead to a stable and capable manufacturing process
o You transfer the assay specific process steps to process validation
• You have a technical responsibility on QC method development & stability during all phases of the assay development projects
o You propose, develop and validate QC methods
o You make recommendations for the performance of experiments in QC areas (including equipment)
o You summarise analyses and interpret data in order to draw conclusions
• You develop strategies for stability testing, QC test panels and implementation of test methods including transfer to and training of QC operations
o You ensure the proper and timely preparation of protocols, reports, technical reviews, risk analysis and other documents
o You ensure compliance with national and international (CE & FDA) regulatory requirements and other applicable guidelines. You oversee quality reporting and documentation related to the development activities
o You present your own work at in-house forums and at outside professional meetings
o You act as the subject matter expert for industrialisation in project core teams
o You participate in discussions at assay development and inter-departmental meetings in order to share information, knowledge, ideas, process improvements and judgment to help establish efficient industrialisation directions
o You participate in and lead troubleshooting activities for established test methods/processes
o You continuously assess development processes and identify improvement opportunities
o You coach, mentor, grow and motivate junior team members and/or lab technicians, and delegate work assignments effectively
Education and experience:
• You have an academic level in engineering, bio-analytical chemistry or equivalent through experience
• You preferably have more than 5 years of experience in Pharma, Biotech, Medical Devices and/or in the IVD industry in area of expertise
• Experience with manufacturing process and QC development activities in a GMP environment is a strong asset
• Experience in methodology for design of experiments and risk analysis is a strong asset
• You have basic knowledge of sample preparation, DNA extraction and real-time PCR
• You have excellent technical writing and reporting skills
• Good knowledge of statistical techniques is highly desirable
• 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