Freelancer profile translated to English.
Back to original languageAbout Alan
With a scientific and technical background, I am passionate about project management and motivated by the desire to take on challenges and contribute to the projects of tomorrow. I work with pharmaceutical companies to structure or strengthen one or more activities. Thoughtful and organized, I also know how to manage projects in urgent contexts.
French
Native or bilingual
English
Native or bilingual
Can work on-site
Nantes (up to 50km), Paris (up to 10km), Lyon (up to 20km), Bordeaux (up to 20km)
Experience
- FreelanceHead of CMC / QC / QA / QualityPHARMACEUTICALS INDUSTRYJune 2024 - Today (2 years)Head of Product Development & QC @OTR3 (since October 2024) :◈ Medical Device and Drug development for commercial activities and advanced clinical stages (phase II/III)- Supervision of QAQC activities and certification of release & stability analysis- Audit supervision of QC department (ISO 13485)- Preparation of tech transfer and industrial scale-up of API production- Preparation of analytical methods transfer to GMP facilitiesCMC & Quality Manager @Lovaltechnology (since July 2024) :◈ Drug development for early clinical stages (phase I/II)- Coordination of development and GMP manufacturing activities- Coordination of analytical methods development and GLP analysis- Review and approval of quality, operational and contractual documentation- Set up and coordination of clinical supply- Writing of CMC parts of CTA and answers to authorities RFIQuality facilitator & QA Manager @MAVIVHe (since March 2025)◈ Setup and management of a QMS for a laboratory conducting analysis on clinical trial samples- End-to-end development and deployment of a QMS- Audit supervision of laboratory (ISO 15189)- Management of analytical operations and documentation complianceQuality facilitator @BioMAP (December 2024 to April 2025)◈ Setup of a QMS for a laboratory conducting analysis on clinical trial samples- End-to-end development and deployment of a QMS- Audit supervision of laboratory (ISO 15189)
- XENOTHERACMC Operations ManagerDecember 2021 - Today (4 years and 6 months)Nantes, FranceManager of pharmaceutical production operations:• Ensure interface and coordination with subcontractors• Planning of active substance production (starting material purification) and finished products (primary and secondary packaging) and management of the supply chain for clinical sites.• Management and supervision of production activities related to active substances and finished products with our external partners (CDMOs). Monitoring of pilot and clinical batch manufacturing and release, from starting material to finished product and transportation.• Management and supervision of analytical activities (transfer, validation, release and stability analyses) with our external partners (CROs). Analysis, interpretation, and verification of the consistency of results with expected specifications.• Drafting, revision, and versioning of production protocols and procedures, study plans, validation plans, and quality documents (statements, product specifications, deviations, change controls...).• Provision of production support documentation necessary for the smooth running of activities.• Drafting of the CMC sections of IMPDs/INDs required for regulatory submissions for clinical trial applications and responses to authorities' questions.• Participation in audits and selection of subcontractors. Responsible for industrial operations:• Coordination with internal teams (R&D, regulatory affairs, clinical, finance) for finished product development and definition of strategy, budgets, timelines, and CMC development plans.• Scale-up, transfer, development, and optimization of production processes and analytical methods (exploratory studies, scale-up).• Definition and continuous improvement of the company's viral safety strategy (incoming material monitoring, process viral clearance, etc.).
- MicrobsR&D EngineerFebruary 2020 - December 2021 (1 year and 10 months)Rennes, FranceMicrobs specializes in the development, production, and marketing of revolutionary microbiological diagnostic kits. The company offers ultra-fast solutions for the agri-food, cosmetic, and pharmaceutical industries, significantly reducing result turnaround times.- Development of Microbs proprietary chemistry, project management, method validation, performance qualification, industrialization of the production process, participation in the implementation of the quality system and production traceability.- Participation in website development and marketing campaigns. Management of prospect/client files via CRM software, from order to delivery. Management of supplies and customer support. Installation of machines at client sites, operator training, and report writing.- Recruitment and supervision of an R&D intern.
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Education
- Engineering Degree, Biological EngineeringCompiègne University of Technology (UTC)2020Diplôme d'ingénieur, Génie Biologique
- Master's Degree, Cellular and Molecular BiologyUniversity of Coimbra2019Master, Biologie cellulaire et moléculaire
Skill set
Categories
- Other