Summary
Overview
Work History
Education
Skills
Timeline
Generic
Costantina Maisto

Costantina Maisto

Atripalda,AV

Summary

Accomplished Radiopharmacist/Quality Control Analyst with a robust background at IRCCS- Istituto Nazionale Tumori "G. Pascale," specializing in the quality control of PET radiopharmaceuticals and peptide synthesis. Expert in chromatographic method validation and adept at fostering lab collaboration, showcasing a blend of technical proficiency and teamwork. Demonstrated success in enhancing quality processes and documentation review, underpinned by a commitment to GMP, GLP, and GCP standards.

Overview

11
11
years of professional experience

Work History

Radiopharmacist/Quality Control Analyst

IRCCS- Istituto Nazionale Tumori "G. Pascale"
02.2016 - Current

Extensive Experience in Quality Control of PET Radiopharmaceuticals: Proven expertise in the quality control of PET radiopharmaceuticals such as [18F]FDG, [18F]Choline, [18F]F-PSMA-1007, [68Ga]DOTATOC, and [68Ga]Ga-PSMA-11, according to GMP in Nuclear Medicine.


  • In-depth Knowledge of NBP/GLP and GCP Standards: Skilled in adhering to and implementing Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) to ensure compliance and excellence.
  • Development of New PET Radiotracers: Initial hands-on experience in quality control of emerging radiotracers, including [18F]AlF-FAPI-74 and [68Ga]Ga-FAPI-46.
  • Chromatographic Method Validation: Proficient in validating chromatographic methods to ensure analytical precision and reliability.
  • Documentation Management:
    Expert in creating, reviewing, and managing production and quality control SOPs, Batch Records, and Instrumentation Log Books.


Technical Expertise:

  • Radio-HPLC Systems; Thin-Layer Radio-Chromatography, Pyrogenicity Assessment, Radionuclidic Purity Evaluation, Chemical Impurity Analysis.


Expertise in the Preparation and Dispensing of Radiopharmaceuticals:

  • Skilled in preparing diagnostic radiopharmaceuticals ([18F]FDG, [18F]F-PSMA-1007, [68Ga]DOTATOC) using semi-automated synthesis modules according to Pharmacopoeia requirements.
  • Proficient in dispensing radiopharmaceuticals with automated systems.


Research and Development Proficiency:

  • Extensive experience in Ga-68 microlabeling of peptides for research applications and monodispersed polymeric compounds.
  • Demonstrated expertise in conducting in vitro and in vivo testing using Micro-PET/CT systems to evaluate the pharmacokinetics and biodistribution of innovative compounds.

Peptides Synthesis

University of Naples "Federico II"
03.2014 - 03.2015

Proficiency in Peptide Synthesis and Characterization:


  • Solid-Phase Peptide Synthesis: Skilled in batch synthesis of peptides and peptidomimetics using solid-phase techniques.
  • Chromatographic Techniques: Experienced in thin-layer chromatography (TLC) and column chromatography for analyzing and purifying compounds.
  • Peptide Characterization: Knowledgeable in applying diverse methodologies to characterize peptide structures and properties.
  • Preparative HPLC Purification: Expertise in purifying peptides using preparative high-performance liquid chromatography (HPLC).
  • Lyophilization: Competent in the lyophilization of target products to ensure stability and usability.

Education

Master of Science - Radiopharmaceuticals Management

University of Salerno
Salerno
04-2019

Master's Degree - Chemistry And Pharmaceutical Technology

University of Naples "Federico II"
Naples
03-2015

Skills

  • Quality management systems
  • Corrective actions
  • Sampling protocols
  • Product Inspections
  • Sampling procedures
  • Testing protocols
  • Data interpretation
  • Documentation review
  • Lab collaboration
  • Quality processes
  • Quality improvement
  • Data validation

Timeline

Radiopharmacist/Quality Control Analyst

IRCCS- Istituto Nazionale Tumori "G. Pascale"
02.2016 - Current

Peptides Synthesis

University of Naples "Federico II"
03.2014 - 03.2015

Master of Science - Radiopharmaceuticals Management

University of Salerno

Master's Degree - Chemistry And Pharmaceutical Technology

University of Naples "Federico II"
Costantina Maisto