Scientist Drug Substance Development
We zijn op zoek naar een enthousiaste kandidaat met ervaring op het gebied van kolom chromatografie voor een DSP Development rol bij een jong en hardgroeiend, innovatief Biotech bedrijf
As a Scientist Drug Substance Development, you contribute to the successful setup, development, qualification and validation of the USP (Upstream processing) and/or DSP (downstream processing) of the Drug Substance development and manufacturing process. You participate in the execution and reporting of Process Characterization, range finding (DoE) and troubleshooting studies for USP and DSP. For this purpose, you draft study plans and study reports and ensure these are correctly documented according to current procedures. You act as a Subject matter expert (SME) for Drug Substance process development.
• Design and execute (hands-on) process development activities for USP and DSP.
• Set up and optimize the drug substance process, together with the Principal scientist DS development and product development team.
• Provide input for the qualification and validation of the USP and DSP process
• Write and review study protocols for the assessment of appropriateness of DS development and for the qualification and validation of the DS process.
• Provide timely and high-quality study plans and study reports
• Participate in writing and reviewing of documents for regulatory submission purposes
• Make recommendations for laboratory equipment purchase, maintenance, calibration, etc. required to perform the above activities
• Provide USP and DSP input during discussions with contractors and the development team.
• Experience with working in an industry setting is a plus
• Experience in biologics process development and characterization (USP and/or DSP), preferably in a pharmaceutical, nutraceutical environment.
• Hands-on experience in upstream processing (fermentation process in bioreactors) and/or downstream processing (purification).
• Knowledge regarding Good Manufacturing Practice requirements is a plus.
• Experience in statistical methods (e.g., Multivariate Data Analysis, ANOVA) is an advantage
• Working with innovative products.
• Develop and Implement Process Improvements.
• Increasing responsibility due to growth of the company.
Voor meer informatie:
Yvette de Kok, Consultant
Telefoon: +31 6 136 70 140