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CMC Manager with 15 years track records in the Biopharmaceutical industry from lead compounds to manufacturing process validation for NCEs and NBEs;

From lead compounds...:

Solid knowledge in synthetic chemistry gained by a PhD in organic chemistry which enabled the development of a new synthesis methodology followed by 2 postdoctoral positions which strengthened my expertise in organometallic and medicinal chemistry process industrialization and validation:

Have been working for 6 years at the chemical process development department of UCB-Pharma before joining the CMC manufacturing group of Ablynx; 12 years background in the fields of process development, industrialization and validation, project and team management and regulatory documents writing for New Chemical and Biological Entities (NCEs and NBEs)

Technical expertise:

Chemical and Bio-process development and validation;

  • development, scale-up and technical transfer for GMP production (for NCEs and NBEs)
  • validation of USP & DSP unit operations (e.g. cell culture, chromatography, diafiltration, clearance and filtration), process hold time validation, TFF/resin re-use and lifecycle, freezing validation, shipment validation, strain stability validation
  • Ongoing/continued process verification

Program management;

  • budget >15M€, planning and resources forecasts -
  • management of outsourced activities (CROs and CMOs)
  • management of multidisciplinary chemical/biotech projects teams (analytical, QC, QA, CMC GMP)

Fluency in regulatory requirements for Pharmaceutical industry;

  • FDA/EMA guidance for industry
  • quality section of regulatory dossiers (MAA, IND/IMPD, Type C and SAWP briefing package)

Personal skills: problem solving, trouble shooting - creative and strategic thinking - passionate - team spirit


Current Experience

  • Senior Scientist - Study Manager Manufacturing CMC
    Since January 2010
    Responsible of all the Caplacizumab CMC related activities: - Project management incl. multidisciplinary team management, budget (>15M€), resources planning) - Management and coordination of multiple CMOs (analytics, manufacturing) to ensure on-time supply of DS and DP materials for (pre-)clinical studies - Process validation for commercial purpose (validation strategy, documentation structure, cQAs assessment, process inputs/outputs criticality assessment and classification, process control strategy, ongoing/continued process verification strategy) - NBEs DS/DP process comparability study - Management of DS & DP regulatory stability studies - Writing/reviewing Quality module in Common Technical Documents (IND, IMPD, briefing docs, MAA)

Past Experience

  • Group Leader
    January 2004 --- January 2010
    Managed DS process development and manufacturing internal or external activities for a new anti-epileptic drug Alternative routes scouting for IP coverage (2 patents) Manufacturing Process transfer (2 transfers including one MCC step (Multi-Column Chromatography) Team management (4-5 degree chemists)

  • Postdoctoral Position
    January 2003 --- January 2004
    In collaboration with UCB Pharma Design and synthesis of compounds acting on CNS as anti-epileptic agents Finalization of multi-step synthetic ways Selection and synthesis of structural derivatives in order to reach required pharmacologic criteria (affinity, activity)

  • Postdoctoral Position
    January 2002 --- January 2003
    Collaboration with UHP Nancy I Study of the potential of new Ni(0) and Co(0) based catalysts for hydrocyanation of butadiene: Synthesis and prove of concept of new catalysts; Design and synthesis of original Ligands.

  • Junior Lecturer
    January 1999 --- January 2002
    Lectures and tutorials in Organic Chemistry for 2nd and 5th year students. Follow up of a student laboratory works in her 5th year trainee period (Research Master)


Self Assessment :
Critical thinkingAdaptabilityCreative thinking


LinkedIn Assessment :
Organic SynthesisHPLCOrganic ChemistryMedicinal ChemistryChromatographynanobodiesBiotechnologyOutsourcing ManagementValidationStability StudiesR&DCROPharmaceutical IndustryBiopharmaceuticalsChemistryLife SciencesGMPTechnology transfer


  • PhD in Organic chemistry from Université Henri Poincaré (Nancy I) in 2002
  • Master in Organic Chemistry from Université Henri Poincaré (Nancy I) in 1997
  • GMP professional training in Continued/ongoing process verification from European Compliance Academy (ECA) in 0
  • GMP Professional training in The validation manager from European Compliance academy (ECA) in 0
  • GMP Professional training in Setting Specification and acceptance criteria from European Compliance Academy (ECA) in 0


BrightOwl Assessment:
Self Assessment:
Full Proficiency
Elementary Proficiency

Area / Region

Lille, France


Driving License
  • Yes