Freelancer profile translated to English.
Back to original languageAbout Margaux
Co-founder of Alter Ego biotech, I bring my CMC skills developed over 12 years in the pharmaceutical industry to biotech companies in the industrialization phases of their process (process design & development, scale-up, tech transfer and validation) by integrating regulatory requirements.
As CMC is addressed too late, the idea is to tackle this subject at the right time and at the right level depending on the development stage and the type of product.
My contribution is both technical (main focus = process) and strategic, and I am keen to do it in a constructive environment by interacting as a partner with biotech companies.
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 50km), Lyon (up to 100km), Strasbourg (up to 100km), Bordeaux (up to 100km)
Experience
- Alter Ego biotechConsultant & Co-FounderApril 2022 - Today (4 years and 2 months)As key partners, we contribute to CMC strategy setting up and provide operational support from pre-clinical stages to product commercialization. We support biotech companies by offering them :- a good understanding of the industrial environment while making sure they meet regulatory requirements- optimized methodologies facilitating their CMC journey- access to a wide industrial network
- SANOFI PASTEURProject LeaderNovember 2015 - March 2022 (6 years and 4 months)Rouen, FranceManufacturing Technology leader for a New Flu Building project:- project management (budget, schedule, team (20+ people)) & transversal work mainly w/ production, engineering & quality teams- flu bulk production process optimization and scale-up (feasibility/development studies...)- process validation (consistency, product stability, product comparability) & support validation (mixing, transport, storage holding times...)- cleaning validation (chemical, CIP, washing machine, holding times...) & viral decontamination validation (material/equipment, cleanrooms and wastes)- practices harmonization with US and Mexico's teams
- TransgeneProcess Development SupervisorMay 2014 - November 2015 (1 year and 6 months)Responsible for vaccine industrial process development and technology transfer: 1) Aseptic process upscale- Cutting edge technology/equipment selection for cell culture and purification steps- Team management (4+ people) according to project priorities/timelines, process development strategy, cost estimate, design and plan experiments, top management reporting- USP dev.: cell culture w/ single-use systems (10-600 mL w/ orbital shaker, 5-20 L rocking motion bioreactor, 5-10 L cylindrical bioreactor, 125 L cubic bioreactor), viral infection, cell banking and viral seed production- DSP dev.: concentration/diafiltration by TFF, cell breakage, clarification, enzymatic steps, chromatography- QbD approach, DoE training 2) Technology transfer- Transfer protocol writing- Ensure technical training 3) Participation in long-term projects design as industrial development service representative
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Education
- Master of TechnologyENSTBB Bordeaux INP2011Master's Degree, Biotechnology
- General University Studies Diploma, Biology & BiochemistryUniversité de Bretagne Sud, Vannes2008Diplôme d'Etudes Universitaires Générales, Biology & Biochemistry
Skill set
Categories
- Other