Profilo professionale
Panoramica
Esperienza lavorativa
Istruzione
Competenze
Lingue
Cronologia
Generic
STEFANO TAFANI

STEFANO TAFANI

Guidonia Montecelio,Rome

Profilo professionale

Associate Scientist with over seven years of experience in pharmaceutical quality control, specializing in chemical-physical analysis, GMP compliance, and laboratory process optimization. Skilled in stability studies, QC testing, and analytical troubleshooting, with a track record of improving workflows, ensuring data integrity, and supporting successful audits. Known for precision, attention to detail, and the ability to collaborate effectively across departments to meet tight deadlines and maintain high quality standards

Panoramica

10
10
anni di esperienza

Esperienza lavorativa

Associate Scientist

Merck Group
Rome
04.2022 - 09.2025
  • Maintained a 90% Laboratory Quality Index through execution of chemical-physical and electrophoresis analyses for stability studies and QC testing, ensuring GMP compliance.
  • Optimized workflows, resources, and turnaround times to meet KQIs/KPIs targets.
  • Reviewed and updated SOPs in line with the EU, US, JP, Russian and Chinese Pharmacopoeia standards.
  • Supported GMP audits, method transfers, and troubleshooting in compliance with regulatory and client requirements.
  • Designated Key Person for planning laboratory workflows and coordinating collaborator activities.
  • Designed ELN/LIMS QC templates, improving data traceability and digital integration.
  • Applied Lean Six Sigma & 5S methodologies to streamline operations, reducing variability and processing time.
  • Trained new colleagues on analytical methods, SOPs, and GMP standards.

Junior Researcher

Merck Group
Rome
04.2018 - 04.2022
  • Performed chemical-physical and electrophoresis analyses for stability studies and QC testing, maintaining a 90% Laboratory Quality Index and ensuring GMP compliance.
  • Executed laboratory tests and documented results in compliance with EU, US, and JP Pharmacopoeia standards.
  • Supported workflow optimization initiatives to improve resource allocation and turnaround times.
  • Assisted in method transfers, troubleshooting, and audit preparations.
  • Collaborated with senior scientists in reviewing and updating SOPs.

Medical Devices Consultant

Di Renzo Regulatory Affairs
Rome
01.2017 - 03.2018
  • Registered over 100 Medical Devices in the Italian NSIS and foreign databases.
  • Advised on Medical Device registration strategies.

Chemical & Microbiological QC Technician

Peroni S.r.l
Rome
06.2016 - 08.2016
  • Performed chemical and microbiological sampling in production lines.
  • Conducted conformity tests for raw materials and final products, including GC and plate counts.

Chemical QC Technician

Farm S.r.l
Rome
05.2015 - 10.2015
  • Analyzed environmental matrices and waste samples for chemical parameters.
  • Implemented a new HPLC method to quantify residual Amoxicillin on garments post-cleaning.

Istruzione

Master’s Degree - Analytical Chemistry

University of Rome 'Sapienza'

Bachelor’s Degree - Chemistry

University of Rome 'Sapienza'

Competenze

  • HPLC
  • UHPLC
  • GC
  • UV/Vis Spectrophotometry
  • TOC
  • Karl Fischer
  • Osmolality
  • Subvisible Particles
  • CCIT
  • Break Off and Gliding Force
  • CE-SDS
  • ICE
  • SDS Page
  • Pharma Tests
  • LIMS
  • NuGenesis
  • TrackWise
  • Empower
  • LabX
  • Discoverant
  • CARA
  • Microsoft Office

Lingue

Italiano
Madrelingua
English
Esperto
C2
German
Principiante
A1

Cronologia

Associate Scientist

Merck Group
04.2022 - 09.2025

Junior Researcher

Merck Group
04.2018 - 04.2022

Medical Devices Consultant

Di Renzo Regulatory Affairs
01.2017 - 03.2018

Chemical & Microbiological QC Technician

Peroni S.r.l
06.2016 - 08.2016

Chemical QC Technician

Farm S.r.l
05.2015 - 10.2015

Master’s Degree - Analytical Chemistry

University of Rome 'Sapienza'

Bachelor’s Degree - Chemistry

University of Rome 'Sapienza'
STEFANO TAFANI