Ségolène Zalecki

Ségolène Zalecki

Process Engineer: Purification Development and Clinical Manufacturing, Glenmark Pharmaceuticals
 

En poste chez Glenmark Pharmaceuticals

Précédents : Crucell, Novartis, Celgene International Sàrl, Glenmark Pharmaceuticals SA, Sanofi Aventis, Merck KGaA

 

Précédents : Université Des Sciences Et Techniques Du Languedoc (Montpellier II), University Of Montpellier II, IUT 1 Joseph Fourier

 

    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.

Parcours

Process Engineer: Purification Development and Clinical Manufacturing

Chez Glenmark Pharmaceuticals

De juin 2013 à aujourd'hui
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.
 

Engineer in Process Development Pilot Plan – Downstream Processing

Chez Crucell

De novembre 2012 à mai 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, ...
Lire la suite
 

Associate Scientist in Protein Purification and Late Phase Process Development

Chez Novartis

De novembre 2009 à octobre 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 ...
Lire la suite
 

Purification Scientist in Downstream Processing

Chez Glenmark Pharmaceuticals SA

De décembre 2008 à avril 2009
Involved in the development of several antibody purification processes.
 

Engineer in Chemistry Process Development (Internship)

Chez Sanofi Aventis

De février 2008 à juillet 2008
Development of a process of an antimalarial drug synthesis and search of the impurity synthesis pathways. Synthesis was designed in manufacturing compatible conditions.
 

Research Engineer (Internship)

Chez Merck KGaA

De avril 2007 à août 2007
Synthesized kinase inhibitors for anticancer drugs targets. Reaction was followed and purified by chromatography (silica, HPLC).
 

IUT 1 Joseph Fourier, Grenoble

DUT in Chemistry (Equivalent to HND), , Chemistry

De septembre 2002 à juillet 2004
 

Compétences

 
  • Antibody
  • Anticorps monoclonaux
  • Assurance
  • Chromatography
  • Développement de procédés
  • Environment
  • Environnement
  • GMP
  • Voir toutes les compétences (17)

Langues parlées

 

Centres d'intérêt

 
  • Ballroom dance
  • Diploma as Holiday Camp Leader (BAFA: Brevet d’Aptitude aux Fonctions d’Animateur en centre de vacances et de loisirs)
  • First aid (AFPS: Attestation de Formation aux Premiers Secours)
  • Squash
  • Travelling
  • Volley-ball (regional federal referee)