Freelancer profile translated to English.
Back to original languageAbout Donatien
Donatien is the head of a young company MLC - MOVE LINES CONSULTING, specializing in consulting and subcontracting on client sites, for drug quality control laboratory activities.
This company stands out for its expertise in the development, validation, and transfer of analytical methods (HPLC, UPLC, GC...). Its objective is to support health industries, particularly pharmaceutical laboratories, so that they can better meet the regulatory constraints and requirements of competent authorities (EMA, FDA, ANSM, ANSES...), responsible for evaluating the quality and safety of drugs and other health products.
It provides support for analytical project management in compliance with regulatory standards (ICH, GMP, FDA...), data integrity principles, and companies' Quality policies.
French
Native or bilingual
Can work on-site
Montpellier (up to 50km), Lyon (up to 50km), Paris (up to 50km), Bordeaux (up to 50km), Strasbourg (up to 50km)
Experience
- WESENSE ELITYS FranceConsultant, Analytical Project ManagerPHARMACEUTICALS INDUSTRYJanuary 2025 - Today (1 year and 5 months)Lyon, FranceProject Management in Development, Validation & Transfer of Analytical Methods on client sites (Major Pharmaceutical Groups)
- Laboratoire Farmaclair (FAREVA)Project Manager for Development, Validation & Transfer of Analytical MethodsPHARMACEUTICALS INDUSTRYJanuary 2024 - September 2024 (8 months)Hérouville-Saint-Clair, France**Context**:
- Transfer of Production of analgesics Baume Aroma 50 g and 100 g from MAYOLY laboratory to Farmaclair laboratory (FAREVA)
- Co-Validation and Transfer of various Methods (2 GC/FID, 2 HPLC/UV and one TLC Method) for the analysis of analgesics from the MAYOLY site to the Farmaclair site (FAREVA)
- Management of technician teams
- Management of Validation Analyses
- Co-Validation of GC/FID Methods for the assay of the first two active ingredients of analgesics
- Co-Validation of the TLC Method, used in the identification of the third active ingredient
- Validation of the HPLC/UV Method for the detection of related substances.
- Management of methods familiarization analyses
- Development of assay methods for other drugs (ancillary projects.)
- Management of Validation Analyses for the various Methods
- Validation of the 2 GC Methods coupled with a flame ionization detector, validation of the 2 HPLC methods coupled with a UV detector, and validation of the TLC method
- Writing of analytical techniques, analytical protocols, and validation reports
- Management of Validation Analyses
- Finalization of the production transfer of analgesics Baume Aroma 50 g and 100 g from MAYOLY laboratory to Farmaclair laboratory (FAREVA)
- Laboratoire ZACH SYSTEMAnalytical Project ManagerRAW MATERIALS INDUSTRYApril 2023 - December 2023 (8 months)Avrillé, France**Context**:
- Management of release testing for active pharmaceutical ingredients, synthesis intermediates, and finished products.
- Management of technician teams (06) for the release testing of active pharmaceutical ingredients, synthesis intermediates, and finished products.
- Planning of analyses, Double checks, and approval of these analysis results in EMPOWER software
- Double check and approval of analysis results for active pharmaceutical ingredients, synthesis intermediates, and finished products in EMPOWER software.
- Entry and creation of result tables for various batches of active pharmaceutical ingredients, synthesis intermediates, and finished products in Excel files.
- Creation of batch control charts.
- Monitoring of any batch deviations.
- Filing of result sheets by project code according to EMPOWER project plans.
- Review and update of analytical protocols according to changes and specification updates.
- Release of batches of active pharmaceutical ingredients, synthesis intermediates, and finished products.
- Creation of certificates and analysis reports
- Creation of batch control charts
- Creation of batch stability studies
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Education
- Professional Master's Degree, Pharmaceutical Sciences, Health Product Development: Quality & Safety trackFaculty of Pharmacy of the University of Montpellier2019Pharmacie Industrielle
Certifications
- Presential training on the Good Practices GuideFarmaclair R&D Department
- Certification to Veeva Vault Document Management SoftwareSanofi R&D