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Guillaume GERARD

BIEDERTHAL

Electionseuropéennes 2024

RETROUVEZ GRATUITEMENTLe résultat des européennes à Biederthal ainsi que le résultat des européennes dans le Haut-Rhin.

En résumé

SUMMARY

Professional engineer with diverse experience in Quality, in CMO management, packaging and pharmaceutical development looking for a new challenge in project management. Experienced working in Quality, tech Ops, R&D environment, factory and managing projects with a diverse team of scientists. Excellent command of French, German, and English and an ability to work in diverse environment acquired while working in several European countries.

Mes compétences :
RFID
Qualité
Galénique
R&D
Packaging
Conditionnement
Gestion de projet
Industrie pharmaceutique
Innovation

Entreprises

  • Sandoz Biosimilars - Drug Product Manager

    2012 - maintenant

  • Novartis - Packaging Development Manager

    RUEIL MALMAISON 2006 - 2012 NOVARTIS AG Basel, Switzerland, Oct 2006 – Today

    Packaging Development Manager

    Capital Acquisition and Technology Implementation:
    - Coordinated the acquisition of several new capital equipment. Identified need, surveyed market, wrote acquisition proposal, conducted acceptance testing
    (FAT/SAT) and qualification (IQ/OQ/PQ) to meet GMP requirements.
    - Conducted cost of ownership analyses which resulted in acquisition of $2M worth of packaging equipment.
    - Involved in manufacturing site transfer projects for several commercial and development products, including solid and liquid dosage forms.
    - Improved manufacturing process for one product by automating a previously manual process.
    - Responsible for selection, coordination and management of 3rd party relationships, including suppliers or materials, processing equipment, and manufacturing services.
    - Provided strategic input on late stage customization and business continuity issues (supplier and site selection).
    - Implemented a cold supply chain.

    Pharmaceutical Packaging and Device Development:
    - Responsible for packaging system and delivery device development. Project experience includes oral solid dosage forms, sterile and non-sterile liquids for parenteral and topical delivery. Involved in development from proof-of-concept to commercialization.
    - Work with marketing to develop packaging strategy.
    - Identify product quality and stability issues, choose appropriate packaging solutions, and lead leachable & extractable studies.
    - Develop design specifications considering product quality and safety, regulatory requirements, HSE (ergonomics/ handling issues).
    - Implementation of a global packaging specification system.
    - Medical device class III development: mini-spike, dispenser set with CE-marking, 510 K documents.
    - Work with project team and legal services to develop research and service level agreements (SLA) with CROs and TPOs for manufacturing clinical packs, child resistant packaging options, etc.

    Authoring of regulatory submission documents:
    - As packaging and manufacturing expert I regularly draft processing instructions, validation reports, and packaging briefs.
    - Support regulatory submissions, draft relevant sections for reports to FDA and EMEA on CMC dossier.

  • SYNGENTA - Project Engineer

    Guyancourt 2003 - 2006 - Project leader for packaging projects. Involved in several product launches in Europe.
    - Participated to the interpretation and implementation of new HSE and manufacturing regulations.
    - Responsible for Packaging Waste Obligations Reports in Europe.
    - Packaging rationalization in Europe.
    - Data capture and analysis with business warehouse for fixed costs and pack costs.
    - Conducted marketing studies focused on packaging.
    - Transport classification control for dangerous goods (UN certification)
    - Introduction on a global level of an intranet site for sharing new ideas and concepts.

  • Schwarzkopf & Henkel - Global Packaging Engineer

    2002 - 2003 SCHWARZKOPF & HENKEL Düsseldorf, Germany, Jul 2002 – Oct 2003

    Global Packaging Engineer
    - Development of packaging for body and hair care products. Involved in the international re-launch of several important brand including Fa Shower Gel, La Toja, Schauma, Diadermine, Schwarzkopf, Taft, Gliss Kur. The development includes cavities mould development: injection moulding and blow moulding technology to on-line testing, product quality tests, including material, transport, label, and storage testing.
    - Involved in the commissioning of a new shower gel filling line.
    - Other activities included new artwork process, identification of cost reduction measures on labels and aerosols, studies on the oxidation of aerosol cans. Process and studies of cost-saving on the cartons pre-printed vs labelled or printed on line technology.
    - Assessment of suppliers with QS manager, Purchasing, and Logistics.

Formations

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