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Ségolène ZALECKI

NEUCHÂTEL

En résumé

I work for Glenmark Pharmaceuticals SA as Process Engineer in Purification Development and Clinical Manufacturing.
My tasks in purification development consist to design purification processes for new drug candidates; perform the scale-up processes to clinical manufacturing scale; and supervise and execute viral clearance studies.
While my role in Clinical Manufacturing is to plan and execute equipment and process validations. I am also involved in the GMP manufacturing of Phase I clinical material in compliance with regulatory and quality guidelines.

Mes compétences :
Antibody
Anticorps monoclonaux
Assurance
Chromatography
Développement de procédés
Environment
Environnement
GMP
manufacturing
Nanofiltration
Pilot
Process
Production
Purification
Quality
Quality Assurance
Ultrafiltration

Entreprises

  • Glenmark Pharmaceuticals - Process Engineer: Purification Development and Clinical Manufacturing

    2013 - maintenant Design purification processes for new drug candidates. Scale-up processes to clinical manufacturing scale. GMP manufacturing of Phase I clinical material. Plan and execute equipment/process validations. Supervise and execute viral clearance studies.

  • Crucell - Engineer in Process Development Pilot Plan – Downstream Processing

    2012 - 2013 Development of vaccine downstream processes and production of material for Phase I clinical studies. Preparation of equipment and control of standard operating procedures, batch records and other compliance documents. Participation in the scale up and the optimization of documentation, processes, and technologies.

  • Novartis - Associate Scientist in Protein Purification and Late Phase Process Development

    RUEIL MALMAISON 2009 - 2012 Involved in the development of several protein and antibody purification processes (from harvesting to drug substance formulation).

    - Small-scale screening.
    - Development and optimization of Purification Processes by chromatography (affinity, ion-exchange, hydrophobic, and multi-mode) and by filtration system (nanofiltration, ultrafiltration).
    - Design of Experiment.
    - Scale-up to pilot scale and transfer to a manufacturing site in GMP environment.

  • Celgene International Sàrl - Junior QA Analyst

    Paris 2009 - 2009 Participation in approbation process for final approval of a pharmaceutical product on the market.

  • Glenmark Pharmaceuticals SA - Purification Scientist in Downstream Processing

    2008 - 2009 Involved in the development of several antibody purification processes.

  • Sanofi Aventis - Engineer in Chemistry Process Development (Internship)

    Paris 2008 - 2008 Development of a process of an antimalarial drug synthesis and search of the impurity synthesis pathways. Synthesis was designed in manufacturing compatible conditions.

  • Merck KGaA - Research Engineer (Internship)

    Darmstadt 2007 - 2007 Synthesized kinase inhibitors for anticancer drugs targets. Reaction was followed and purified by chromatography (silica, HPLC).

Formations

  • Université Des Sciences Et Techniques Du Languedoc (Montpellier II)

    Montpellier 2007 - 2008 MASTER, Synthèse Appliquée, Séparation et Analyse

    Chemical Engineer in biomolecular engineering

  • University Of Montpellier II (Montpellier)

    Montpellier 2004 - 2007 IUP degree Chemical Engineer

  • IUT 1 Joseph Fourier (Grenoble)

    Grenoble 2002 - 2004 DUT in Chemistry (Equivalent to HND),

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