Experience

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  Galderma

  Jan 1997 - Apr 2018

  Key responsibilities as product development project manager: • Lead and manage CMC development project teams including formulation, analytical development (quality control, packaging ,stability, microbiology) and pilot manufacturing within pharmaceutical development, or with subcontractors or with license partners in the area of pharmaceuticals, biologics, cosmeceuticals, aesthetics and neutraceuticals.• Organize the technology transfer / scale-up from R&D to the manufacturing sites for clinical batches and registration batches• Provide integrated CMC plans with timelines, mendays, costs, risk analysis and risk mitigation • Assure CMC leadership/Alliance Manager function in international projects Key responsibilities as CMC expert: • Build the CMC regulatory strategy, review TPP, CCDS, and other regulatory documents•Take responsibility for the CMC section of Regulatory dossiers (Briefing Packages, Investigator’s brochures, IND/IMPD, CTD, IDE, PMA, BLA), • Attend Scientific Meetings with Health Authorities (FDA, EMA, national agencies) and Pre approval inspection manage efficiently the Response to questions from Authorities during the review process including geographical roll out, • Contributed to the evaluation of new opportunities (due diligence) in Pharmaceutical field Show less

  • Senior Product Development Project Manager -Senior CMC Expert

    Jul 2006 - Apr 2018

  • Formulation Development Manager

    Jan 1997 - Jun 2006
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  Blue reg pharma consulting

  May 2018 - Oct 2020

  Director, cmc, drugs and biologics

  • Strategic consultancy during global pharmaceutical development and life cycle management o Development of API (small molecules, peptides, biological, herbals) o Strategic advices in drug product development: formulation, scale-up, analytical development, validations, gap analysis, process scale up, manufacturing strategy, shelf life for stabilities o Due diligence, gap analysis and expert reviews• CMC regulatory strategy and expertise: o Build CMC regulatory strategy for new products and propose communication and meetings with health authorities (EU/US/Export countries) o Assessment and preparation of regulatory documents: IND, IMPD, MAA and NDA / BLA module 3, response to agencies questions. o Maintenance of products on market: post MAA/lifecycle management with CMC variations• Project management: coordination of all activities in pharmaceutical development from API selection, product development, clinical supplies, transfer to CMO, to registration • Team Management: Management of a team of senior consultants• Business development of the CMC activities, digital marketing Show less

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  Iteos therapeutics

  Oct 2020 - now

  Vp, global head of cmc

  • Immuno -oncology area, small molecules (NCE) and large molecules (NBE)• Head of the CMC Department, reporting to COO, in charge of global CMC development, from early stage (lead candidate selection to FIH; Phase II) to late clinical stage (Phase III; registration)- resources, budget, strategy.o Lead and oversee Operational activities in NCE and NBE: solid state studies or developability/ formulatability, DS process development or cell line construction/MCB/WCB, DP early formulation, DS and DP scale up, analytical method development and validation, stability studies, clinical/registration/PPQ batches, preclinical and clinical supplies.o Define CMC regulatory strategy, responsible for the regulatory documents (IND, IMPD, Module 3, response to agencies questions).o Align and coordinate the CMC due diligence activities o Coordinate the CMC QMS and contribute to the Quality Review Boardo Successfully manage an internal team of CMC Subject Matter Leaders, external consultants and CDMOs. Show less