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Alexis COLLETTE

PARIS

Résultats examens 2026

RETROUVEZ GRATUITEMENT Le résultat du bac à ParisLe résultat du brevet à Paris Le résultat du BTS à Paris

En résumé

Mes compétences :
bioinformatics
Immunology
management
CMC development
GMP
GLP
Bioanalysis
Biotechnology
Statistics
Cell therapy
Gene Therapy

Entreprises

  • Analytical Development & Bioanalysis consulting and transition management - Senior Consultant, Analytical Development

    2017 - maintenant Serving international biotechs to address their scientific, technical & operational challenges.

    Analytical development/Bioanalysis
    • Lab operations support
    • Method development, validation, transfer & testings
    • Outsourcing management
    • GMP/GLP compliance
    • CMC strategy
    • Regulatory files / Q&A

    Management & leadership
    • Operational excellence, Role & Responsabilities, New processess
    • Transition, Change & Crisis management
    • Due diligences & expertise

  • Stallergenes Greer - Senior Director, Analytical Development

    ANTONY 2014 - 2017 (Immunotherapy medicinal products targeting allergy: 1,400 FTEs, 2014 TO € 280M)
    Senior Director, Analytical Development

    Analytical development
    • Designed and headed the implementation of strategies for the development of active Drug Substances and Products
    • Developed/validated/transfered compendial or non-compendial methods in Immunology,Chemistry & Microbiology
    • Fostered innovation and upgraded technical resources
    • Oversaw lab activities: GMP compliance, Quality Events (CAPA, OOS, OOT), IQ/OQ/PQ qualification, critical reagents
    • Compliance with all relevant French and foreign referentials (ICH/EMA/FDA guidelines & USP/EP/JP Pharmacopoeiae) and SME/process owner during ANSM/FDA/PMDA inspections
    • CMC team leader for House Dust Mites tablets

    Management & leadership
    • Lead a department of 54: 4 group leaders, 13 team leaders, 37 technicians: recruitment, training, coaching, resource allocation.
    • Managed financial resources (€1-2M OPEX, €0.5-1M CAPEX, personal costs, ROI), budgets, contracts and quality agreements.
    • Change management: reorganized and integrated 2 teams, setup new processes for Specifications and LCM,
    • Coached collaborators for project management and transversal teams.

  • Texcell - Co-founder & VP, ImmunoProfiling

    Évry 2003 - 2014 (Services in Biosafety and Bioanalysis for biological pharmaceuticals products
    From 15 FTEs/one site to 60 FTEs/two sites in France and in the USA)

    Corporate / Finance
    • Cofounder and Member of the Board (2007-2013) of TEXCELL and SOPARBIOTECH (holding)
    • Business plans, Road-shows, forecasts, P&L

    Creation and management of a new Business Unit: ImmunoProfiling (Turnover: 900k€, 7-10 FTE)
    • Coordinated Lab installations, planning, budget, IQ/OQ/PQ qualification, 21 CFR 11
    • Structured and managed the teams: recruitment, training, coaching, resource allocation
    • IP, CDAs, supervised contracting and lead negotiations
    • Managed subcontractors/CRO: in vivo studies & clinical sample logistics
    • Supervised R&D, collaborations and grants (ANVAR, OSEO, PM’UP, EU FP7): 900k€
    • Implemented Scientific and Regulatory watch (ICH/EMA/FDA/ANSM...)
    • Implemented Sage X3 ERP and Agilent Electronic Laboratory Notebook software

    Business Development for ImmunoProfiling BU (2011-2014)
    • Sourcing / key accounts management, flyers, RFP/RFI
    • Co-created TEXCELL’s day on Cell & Gene Therapy (ATMP)

  • Université Paris 6 Pierre et Marie Curie - Moniteur

    1999 - 2002 Teaching basic programming

Formations

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