Experience

Debiopharm

• Switzerland
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Analytical Development & Quality Control Manager, CMC Project Leader, Pharmaceutical Development

  • Jan 2021 - Present

• Senior Scientist, Analytical Development & Quality Control, CMC Pharmaceutical Development

  • Sep 2016 - Jan 2021

  Responsible for the analytical development strategy (method development/validation, specifications, stability studies, retest date) for drug substance (NCE) and drug product and execution thereof according to the CMC plan (from drug substance characterization through formulation and process development and regulatory submissions) for various development projects (small molecules, peptides, radiopharmaceutical products). Therapeutic fields : oncology and infectious diseaseDevelopment stages : Phase 1,2,3 Show less



FAMAR

• Greece
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Transfer & Development Manager

  • Nov 2007 - Sep 2016

  Analytical expertise -development/validation, transfer of analytical compendia or non-compendia chemical and microbiological methods on drug substance, excipient and drug product (solid, semi-solid and liquid forms) -strong technical knowledge in spectroscopic (UV/IR/NIR), chromatographic (LC, GC), dissolution methods and other common techniques used in a pharmaceutical QC laboratory (Eur Ph/ USP) -support for process validation (trial/scale-up/engineering/validation batches) Quality role -management of investigation processes -management of stability studies processes -support for Regulatory Affairs department -auditor role Project management -team leader in the development/transfer cross-disciplinary project teams (supply, engineering, manufacturing, quality, finance, purchasing) -management of analytical services portfolio for the QC laboratory and quotation services for new products in collaboration with finance department -project manager for « QC performance - lean lab year 2015» Show less



Patheon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Transfer & Development Leader

  • Jan 2005 - Apr 2007

  In charge of analytical activities of a global site transfer project (commercialized products): method transfers, coordination of methods development/validation for CTD upgrades, support for process validation, management of stability studies

• QC Manager

  • Jul 2004 - Dec 2004

  Team management : 25 technicians (microbiology and chemical laboratories)Equipment qualificationAnalysis management : planning, follow-up, testing release (raw material and finished product)



Skyepharma

• France
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Analytical Development Leader

  • Jul 2003 - Jul 2004

  In charge of analytical activities associated to several products under development (phase III): method validation, analysis of trials and scale-up batches (for clinical purposes), management of stability studies In charge of analytical activities associated to several products under development (phase III): method validation, analysis of trials and scale-up batches (for clinical purposes), management of stability studies



Merck Healthcare

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Manager Deputy

  • Oct 2002 - Apr 2003

  Team management : 25 technicians (microbiology and chemical laboratories) Equipment qualification Analysis management : planning, follow-up, testing release (raw material and finished product) Team management : 25 technicians (microbiology and chemical laboratories) Equipment qualification Analysis management : planning, follow-up, testing release (raw material and finished product)



SmithKline Beecham, Tonbridge, UK

• Tonbridge, UK

• R & D Analyst

  • Aug 1999 - Aug 2000

  Analyst in chromatographic department (Liquid and Gas Chromatography, Ionic chromatography, Capillary Electrophoresis) Analyst in chromatographic department (Liquid and Gas Chromatography, Ionic chromatography, Capillary Electrophoresis)