Basel Metropolitan Area
Drug product specialist with a strong experience in formulation of recombinant proteins and viral vectors. Method development and analytical techniques implementation in a pharmaceutical R&D environment from early to late stage development. Formulation platform implementation, predictable timelines using automated high throughput formulation and data processing. Personal mantra : "If you don't know, ask. If you do know, share" and "Inherent particles should be understood and controlled" - USP <1787>
Formulation platform design and implementation for AAV based gene therapy. High-throughput formulation screening Scale-down models, tech transfer, late stage implementation and scale-up. Physico-chemical characterisation of various AAV serotypes. IND, IMPD writing (module 3) Drug product development for IV, intrathecal, intrastriatal administration. Devices compatibility (CED, IV, IT, IM, CSTD).
Vaccines - Drug Product Development Formulation of recombinant adenoviruses, inactivated/attenuated poliovirus and recombinant proteins. Formulation and analytical method development for the Formulation Development platform in a GRP environment. Implementation of an High Throughput (pre-)Formulation platform using Automated Liquid Handling workstation (Hamilton STAR method Development) Working on antigens stability studies, design and formulation selection of viruses and recombinant proteins in adjuvanted systems (virosomes, alum) Device compatibility (prefilled syringes, syringes, CSTD) Monitoring protein content, conformation and aggregation using well known and innovative analytical techniques such as Spectrophotometry, Fluorimetry, Dynamic Light Scattering, Fluorescence Microscopy... Data handling, reduction and analysis
High scale virus purification in a GMP environment Operations in Aseptic MSL3 (Class A/B) room Member of user team in the scope of starting a new manufacturing facility
Analytical method development for High-Throughput Formulation platform Working on antigens stability studies, construction design and formulation selection of viruses and recombinant proteins in adjuvanted systems (emulsions, Alum, liposomes) Monitoring protein content, conformation, chemical degradation and aggregation using well known and innovative analytical techniques : Spectrophotometry, Calorimetry, Light Scattering, Liquid Chromatography, Capillary Electrophoresis Data handling, reduction and analysis
Purification of recombinant proteins for structural biology and screening purposes. Purification method development using Äkta systems (Explorer, 3D)