Freelancer profile translated to English.
Back to original languageAbout Mathilde
Biotechnology engineer, I offer my services to help you in the implementation and monitoring of your analytical methods throughout the development of your pharmaceutical products. This can concern Analytical Quality by Design (AQbD), method validation/transfer/equivalence (with associated documentation: Plan/Protocol/Report) and data compliance/quality aspects (Data Review, Audit). I also have experience in the analytical strategy associated with Process Validation.
French
Native or bilingual
English
Fluent
Remote only
Primarily works remotely
Experience
- TREEFROG THERAPEUTICSAnalytical Subcontracting and Compliance ExpertDecember 2024 - Today (1 year and 6 months)33600 Pessac, France• Management of various analytical subcontractors: contracts in collaboration with the legal department, quotes, analysis planning, project monitoring, analytical report review• Definition of quality requirements and establishment of a strategy for the analytical team transitioning from R&D to GMP, management of associated documentation• Monitoring of the audit readiness plan in collaboration with the QA department• Participation in batch reviews and monitoring of stability studies
- ENGINEERING MEDICAL APPLICATIONApplication Engineer SouthwestNovember 2023 - January 2024 (2 months)Aix-en-Provence, France• Management of users of the tool located in their area (Hospitals, Clinics, Dialysis Centers)• Provide technical support and training in person or remotely• Promote new tools and customer loyalty for their portfolio
- MERCK BIODEVELOPMENTAnalytical ExpertOctober 2017 - June 2023 (5 years and 8 months)Martillac, France• Management of client (international) or internal projects for the development of biotechnological molecules• Implementation of the analytical strategy: panel of methods, studies (equivalence, transfer, validation), planning, costs• Writing of analytical documents (procedures, validation plan, protocols, reports)• Supervision of activities ensuring laboratory compliance (equipment qualification, procedures, deviations)• Implementation of new tools and team training (document templates, planning file, quote file, statistical software usage)• Participation in the recruitment of new employees
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Education
- Health Biotechnology EngineerONIRIS Engineering School2015Ingénieur Biotechnologies de la Santé
- Bachelor of Cell Biology(University of Rennes2012Licence de Biologie Cellulaire
Skill set
Categories
- Other