BrightOwl Loader Loading

Summary

cmc manager with 15 years track records in the biopharmaceutical industry from lead compounds to Manufacturing process Validation for nces, nbes and gt products;

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

...to 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;

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

Experiences

Current Experience

  • Sr. CMC Manager

    Paris, France
    Since November 2017

    responsible for technical Project Management of aav based Gene therapy development projects;
    - management and supervision of cmc activities relating to vivet products under GXP requirements 
    - responsible of technical development Strategy and integration into the overall project Strategy to meet program timelines and budget for all cmc activities 
    - delivering of the product designs, the cmc regulatory Strategy, and ensure cmc readiness for regulatory filing and Health authority responses.

    Responsible for technical project management of AAV based gene therapy development projects;
    - Management and supervision of CMC activities relating to Vivet products under GxP requirements 
    - Responsible of technical development strategy and integration into the overall project strategy to meet program timelines and budget for all CMC activities 
    - Delivering of the product designs, the CMC regulatory strategy, and ensure CMC readiness for regulatory filing and health authority responses.

  • Senior Scientist - Study Manager Manufacturing CMC


    Since January 2010

    responsible of all the caplacizumab (cablivi) cmc related activities conducting product from early ph.ii to Marketing submission. - 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)

    Responsible of all the Caplacizumab (Cablivi) CMC related activities conducting product from early Ph.II to marketing submission. - 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)

Personality

Self Assessment :
Critical thinkingAdaptabilityCreative thinking

Knowledge

LinkedIn Assessment :
Organic SynthesisHPLCOrganic ChemistryMedicinal ChemistryChromatographynanobodiesBiotechnologyOutsourcing ManagementValidationStability StudiesCROPharmaceutical IndustryBiopharmaceuticalsChemistryLife SciencesGMPTechnology transfer

Skills and Expertise

Self Assessment :
Represent CMC team Build the CMC development planDevelopment of late-stage cGMP production processesDevelop ICH/GCP compliant processesproduct life cycle

Education

  • 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 0000
  • GMP Professional training in The validation manager from European Compliance academy (ECA) in 0000
  • GMP Professional training in Setting Specification and acceptance criteria from European Compliance Academy (ECA) in 0000

Training and Certification

  • Validation Manager in 2017 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
Dutch
Elementary Proficiency

Work Preferences

  • Locations I am interested in:
    Belgium France Ghent, Belgium Lille, France Paris, France
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Lille, France

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in France

Other Candidates in Lille

Other similar Candidates in Lille

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like