Brussels Metropolitan Area
Analytical scientist in the pharmaceutical industry with over 10 years of experience. Personal skills: • Ability to work independently as well as within an interdisciplinary team: R&D, pilot, manufacturing, QC, QA, RA, statistics and IT departments. • Project management: planning, coordination, KPI analysis, standards establishment. • Adequate knowledge on report making, presentation, project proposal and preparation of manuscript. • Computer literate: MS Office, MS Project, MS Visio, bibliography manager. Scientific skills: • Development, validation, transfer and life cycle management of analytical methods according to the Quality by Design (QbD) framework. • Process Analytical Technology (PAT) for monitoring and control of DS and DP manufacturing (batch and continuous). • Spectroscopic techniques: IR, NIR, Raman. • Chromatographic techniques (HPLC, UHPLC, GC, SFC) and hyphenated techniques to mass spectrometry (LC-MS/MS, SFC-MS/MS, GC-MS) for quantification of API and impurities. • Management of supportive and commercial stability studies. • Chemometrics: multivariate data analysis (PCA, PLS,...), signal processing, design of experiments (DoE), method validation and transfer, process comparability, control charts, shelf-life determination, and specification establishment. • Deep understanding of pharmaceutical concepts and regulatory requirements: GMP, GLP, USP, Ph. Eur., EMA, FDA & ICH guidelines. • Programming (Matlab, VBA/VB), deep knowledge of software for statistics (Unscrambler, Simca, PLS Toolbox, JMP), for PAT (SIPAT, FTSW100) and for chromatography & MS (Empower, ChemStation, Analyst). • Technologies watch (publication & patent).
- Development, validation, transfer and life cycle management of fit-for-purpose PAT/spectroscopic methods according to QbD principles for DS and DP. - Support of process development by collection of real-time and in-process measurements. - Control of manufacturing process and method transfer to QC, IPC lab and manufacturing departments. - Data analysis and processing using advanced statistical tools. - Automation of data workflow according to data integrity. - Writing and reviewing of scientific reports and quality documentation. - Active participation to project and scientific meetings. - Follow-up of scientific literature and implementation of state-of-the-art analytical methods. - Coordination and support for CMC submission (analytical part) of therapeutic peptides (characterization, stability studies DS & DP,..).
- Development, validation, transfer and life cycle management of fit-for-purpose PAT/spectroscopic methods according to QbD principles for DS and DP. - Support of process development by collection of real-time and in-process measurements. - Control of manufacturing process and method transfer to QC, IPC lab and manufacturing departments. - Data analysis and processing using advanced statistical tools. - Automation of data workflow according to data integrity. - Writing and reviewing of scientific reports and quality documentation. - Active participation to project and scientific meetings. - Follow-up of scientific literature and implementation of state-of-the-art analytical methods.
Management of the analytical method lifecycle and the stability studies for a marketed vaccines.
Management of the analytical method lifecycle and the stability studies for a marketed bioproduct.
Stability processes improvement for vaccines.
Development of an analytical platform for the analysis of metabolites in cell culture (spent)media using LC-MS/MS, SFC-MS/MS and GC-MS.
Development, validation and implementation of a Process Analytical Technology (PAT) approach involving near infrared (NIR) spectroscopy to control the manufacturing of an active pharmaceutical ingredient.