What are your responsibilities?
- 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.
- 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
Who are we looking for?
- Preferably 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 strong asset
- Experience in methodology for design of experiments and risk analysis is a strong asset
Specific professional knowledge
- Basic knowledge of sample preparation, NA extraction and real-time PCR
- 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
- Cross-functional team player with well-developed interpersonal skills and able to work independently
- Scientific integrity
- Result oriented
What does QbD offer you?
- A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.
But most of all..
- Working for the Antwerp Young Entrepreneur of 2019!
- A flat organization in the broadest sense of the word
- An increase in your IQ through our extensive training package
- A hip office with air hockey table
- More muscle mass through our weekly boot camps
- 32 vacation days that you wish were fewer (because it's great to work here 😉 )
- In short … We work, we play, we deliver, we are Quality by Design!