Mes compétences :
Biotechnologie
CMC
Contrôle qualité
Qualité
Entreprises
Voisin Consulting, Boulogne, France
- Project Director CMC
2008 - maintenantVoisin Consulting provides support to healthcare product developers and contributes to various activities ranging from the design of regulatory strategies, coordination of the interaction with regulatory agencies/Notified Bodies and the preparation of dossiers for submissions to local agencies, EMEA and FDA (i.e. CTA/IND/IDE, MAA/BLA-NDA, CE mark dossier/PMA-510k). Products include drugs, biologics, Gene and cell therapy and tissue-engineered products, medical devices, combination products (devices/drugs.
To achieve this, we propose complementary regulatory services and provide the appropriate expertise to fulfill the various sections of regulatory filings. Amongst these services, the Chemistry Manufacturing and Control (CMC) group provides CMC support to drugs and biologics product developers. Our staff has previous pharma/biotech industry experience combining technology development and transfer, analytical development, quality control and CMC regulatory. This makes us well prepared to interface efficiently with the technical and regulatory teams and help coordinate CMC activities in line with the development phases of our client’s programs.
Examples of activities:
Pharmaceutical sections of IMPDs for Clinical Trial Applications, Module 3 and 2.3 of MAA or BLA/NDA submissions, briefing package for Scientific Advice or Protocol Assistance. We participate in agency meetings to discuss CMC questions and strategy at different stages of development. As process often evolves in the course of development we also participate in the design of comparability strategies to allow bridging clinical development. We also prepare Viral Safety Dossiers for biological products and provide recommendations for overall Viral Safety strategy.
On the technical side, we are often involved in the management of complete technical transfer projects in the context of manufacturing site changes, this include identification of CMOs and analytical laboratories, coordination of manufacturing and method transfer, validation, GMP audits, etc. On these types of projects we often become part of our client’s team and our role consist in interfacing with all parties and groups engaged in the program in order to ensure appropriate information is generated and gathered for efficient regulatory submission.
Genzyme Flanders, Geel, Belgium
- Head of Analytical development
2005 - 2008- Establish an analytical development group in support of a new manufacturing plant designed to produce recombinant proteins and monoclonal antibodies at the 10,000L scale:
/Responsible for hiring of the technical staff, implementation of systems and procedures, purchase and qualification of analytical equipment.
/Provide analytical support to process development and manufacturing and participate in process validation exercises. Highly involved in method development, validation and transfer to Analytical Development and Quality Control. Continuous awareness of cGMP and regulatory guidelines. Active participation in assay troubleshooting and investigations.
/Involved with the development of internal global guidelines for assay qualification, validation, and transfer.
- Project lead in a matrix organization managing teams of up to 20 people representative of R&D, QC, QA, RA, Process Development, Manufacturing:
/Act as the analytical lead in our collaborations with international pharmaceutical companies and coordinate technology transfer activities across multiple sites.
/Comparability project lead: Responsible for the development of our biochemical comparability strategies. Participation in meetings with FDA and EMEA to present the comparability approach involved in a manufacturing site transfer.
Genzyme Corporation, Cambridge USA
- Associate Director
2004 - 2005- Lead a team of 1 Scientist and 4 Analysts.
- Worked in collaboration with R&D, Technology Development, Validation, Quality Control to develop, implement, validate, and transfer the methods necessary to support process development, process qualification, and GMP production of glycoprotein and antibody products.
- Managed international collaboration with Genzyme Polyclonals (France) and Genzyme Flanders (Belgium) to evaluate and implement analytical tools necessary to support process development efforts.
- Worked closely with Regulatory Affairs, QC, and QA to participate in the design of Comparability Protocols, Assay Validation and Assay Transfer guidelines. Participated in laboratory audits and FDA inspections.
Genzyme Corporation, Cambridge, US
- Principal Scientist
2000 - 2004Analytical Development/biotech products. Development of methods specificic for protein and carbohydrate analysis. Glycoprotein and monoclonal antibodies. Qualification/validation.
