Experience

• 

  Decantum systems s.l

  Jul 2005 - Oct 2014

  Decantum Systems is a research and development company of innovative reagent kits for extraction of veterinary residues in food (biological matrices of animal origin) and abuse, psychiatric and doping drugs in human matrices. The detection and quantification will be carried out using GC, GC/MS, HPLC or LC/MS.We have also developed other innovative reagents to identify drugs in powder and tablets through colorimetric reactions in seconds.These techniques are fast, easy, cheap, useful and effectives. They are validated according to Guidance for Industry, Bioanalytical Method Validation (FDA, 2001) and complying with the maximum limits required by European Legislation. They allow detecting food fraud and respond quickly to food alarm. Not only that, but also allow best clinical, toxicological, forensic and doping control.These kits can be used in the following sectors: food safety, animal and human health, toxicology, anti-doping control, psychiatric and forensic analysis.The great advantage of this technology is that´s adaptable to any need on market. Show less

  • Technical Manager

    Apr 2011 - Oct 2014

  • Researcher and Production Responsible

    Jul 2005 - Mar 2011
• 

  Intertek schweiz ag

  Nov 2014 - Jul 2022

  Project manager analytical testing

  Management of projects within pharmaceutical sector for extractables and leachables analysis (e.g, antioxidants, light stabilizers, processing additives) using different chromatographic techniques (TDS-GC/MS, Headspace-GC/MS, GC/MS with and without derivatization, HPLC-UV/MS, ICP/MS).High experience in:- Extractables studies in different container closure systems such as vial & stopper, pre-filled syringes, transdermal patches, ampules, bottles, etc.- Leachables check in drug formulation and/or placebo (e.g, vaccine, opthalmic solution) from accelerated and stability samples to evaluate compounds which could release from the CCS.- Leachables studies in stability drug formulation under GMP procedure (including validation according ICH validation guideline, ICH Q2 (R1), SOP and leachables testing).Deep knowledge in Regulatory, e.g:- USP 1663 and 1664.- Extractables and Leachables (BioPhorum Operations Group, BPOG)- ICH Q1A_R2, Q2(R1), ICH Q3C_R5, ICH 3D, ICH M7.- ISO 10993 (medical devices).- Guideline on the limits of Genotoxic Impurities (CPMP/SWP/QWP/4446/00 corr)- Guideline on the Limits of Genotoxic Impurities (CPMP/SWP/5199/02and EMEA/CHMP/QWP/251344/2006)- Recommendations from PQRI Leachables and Extractables Working Group for: - Orally Inhaled and Nasal Drug Products (OINDP) - Parenteral and Ophthalmic Drug Product (PODP) Show less

• 

  Novartis

  Jul 2022 - now

  Senior expert science and technology (extractables & leachables ch)