Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic
Ayelén Rapoport

Ayelén Rapoport

San Carlos de Bariloche

Summary

Professionally, I am motivated by the implementation of scientific and technological projects, with the objective of generating tangible and measurable results. Throughout my professional experience, I have acquired the necessary skills to understand innovation processes, which has allowed me to develop practical experience in all stages of these processes. In the performance of my duties, I have acquired skills in complex problem solving, strategic planning, prioritization and project management for their implementation.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Clinical Research Associate

Fundación INTECNUS
06.2021 - Current
  • Evaluation of economic and technical feasibility 12 clinical protocols. Negotiation of budgets and contracts. Evaluation of clinical protocols with respect to the center's capabilities and the amounts required for their development, patient recruitment and adherence.

Technology Transfer Office Manager

Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
12.2022 - 12.2024

Manager, Technology Liaison and Technology Transfer in Health, Agriculture and Biotechnology.

Coordination in technology transfer with a 20% increase in the approval of R&D agreements; Responsible for Negotiation and Licensing:

  • 16 technology licenses negotiated and processed
  • 24 Research and Development agreements
  • 6 technological assistance
  • Evaluation and approval of 124 High Level Technological Services.

Responsible for management and strategies for the generation of technology-based companies and Start ups.

  • 15 advised technology-based companies and Start ups, including Galtec, Dharma, Apolo, Mesenchimall, Oncoliq, Oncoprecision, Libera, Hz4 Liver, New Organs.

Responsible for planning and managing the supply of technologies with high industrial value in health:

  • Method of combined treatment of Spinal Muscular Atrophy Spinraza Valproic
  • Micro RNAs for the treatment of diseases associated with neurodegenerative Tau protein.
  • Oral vaccination platform Cysteine-rich proteins.
  • Soybean for high density planting by inhibition of the Shade Avoidance system.
  • Waterlogging tolerant crops associated with Homeobox from sunflower.
  • Monoclonal antibody against new therapeutic target MicA in oncology treatments.

Regulatory Affairs Specialist

CONICET
02.2021 - 12.2024
  • I carried out the processing of 6 experimental trials in contained and confined field conditions.
  • Managed the registration of a biosafety greenhouse in Mar del Plata.
  • Managed the regulatory compliance of the biosafety greenhouse of IAL-CONICET.
  • Drafted 3 dossiers for veterinary vaccines, for dogs and cats, poultry and livestock.

Regulatory Specialistin Genome Editing

CONICET
02.2021 - 12.2024
  • Planning, management and approval of 6 genetically edited pigs for xenotransplantation, under biotechnology regulatory standards, transferred to New Organs.
  • Approval of 2 edited tomato lines for tolerance to fungal infections
  • Approval of drought tolerant rice
  • Approval of potato crop edited for pathogen tolerance
  • Planning, management and approval of edited Cannabis cbd hypothetical product; and Shade avoidance soybean.

Member of CONABIA

CONICET
02.2021 - 12.2024

Biosafety and biological containment expert

Project Manager

Consejo Nacional De Investigaciones Científicas Y Técnicas (CONICET)
11.2020 - 12.2022
  • Management of COVID-19 related projects:
  • 70 projects associated with detection, treatment and prevention.
  • 7 projects of vaccine against Covid,
  • 1 platform for monitoring the results of Covid clinical trials,
  • 25 projects of detection methods, 4 projects of chaps and hospital protection elements, 3 respirators, among others.
  • Management and processing of health projects associated with bronchial tracheoma and rare diseases. Treatment project for neglected diseases, in progress.

Regulatory Affairs Manager

Biotechnology Directorate - CONABIA
04.2016 - 10.2020

Vaccine risk assessment and vaccine trial evaluation.

Technical feasibility assessment of biotechnology projects.

Optimization of the evaluation process of regulatory dossiers, drafting of 4 regulatory standards with their respective forms.

Updating of biosafety and gene editing regulations for microorganisms.

Responsible for risk assessment, analysis and management, evaluation of 8 regulatory dossiers for commercialization.

Technical responsible for validation of molecular detection methods and biomarkers, evaluation of two methods for detection of events in grains.

Drafting of OECD guidelines.

Research and Development Intern

Instituto De Investigaciones Médicas A. Lanari (UBA)
09.2012 - 06.2016

Development of methods for identification of microorganisms of clinical relevance.

Preparation of culture media and environmental quality control, PCR and real-time PCR. Development of biomarkers in hospital infections. Microbiological control of hospital areas. Development of three methods for detection of microorganisms. Development of a method for rapid detection of KPC resistance.

Project Intern

Ministerio De Agricultura. Dirección De Pueblos Originarios
09.2012 - 06.2016
  • Intellectual property and genetic resources, Convention on Biological Diversity and international treaties.

Education

Maestría - Ciencia Tecnología y Sociedad

UNQUI

Licenciatura - Biotecnología

UNSAM
01.2017

Escuela Agrotécnica - undefined

Escuela Agrotécnica 717
Lago Puelo, Provincia de Chubut
01.2000

Associate of Applied Science - Clinical Trials Monitor

FEFyM
Facultad De Farmacia Y Bioquimica
03-2025

Skills

  • Software de Bioinformática, Mega, FinchTV, Blast, T-Coffe, Primer 3
  • Microsoft office, project
  • Inglés - Escrito y oral, avanzado
  • Critical thinking
  • Excellent communication
  • Organizational skills

  • Calm under pressure
  • Organization and time management
  • Decision-making
  • Flexible and adaptable
  • Teamwork and collaboration
  • Problem-solving

Certification

Clinical trials Monitor - FEFyM

Clinical trials coordinator - FEFyM

Health technology assessment and economic evaluation - IECS


Languages

English
Bilingual or Proficient (C2)
French
Beginner (A1)

Timeline

Technology Transfer Office Manager

Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
12.2022 - 12.2024

Clinical Research Associate

Fundación INTECNUS
06.2021 - Current

Regulatory Affairs Specialist

CONICET
02.2021 - 12.2024

Regulatory Specialistin Genome Editing

CONICET
02.2021 - 12.2024

Member of CONABIA

CONICET
02.2021 - 12.2024

Project Manager

Consejo Nacional De Investigaciones Científicas Y Técnicas (CONICET)
11.2020 - 12.2022

Regulatory Affairs Manager

Biotechnology Directorate - CONABIA
04.2016 - 10.2020

Research and Development Intern

Instituto De Investigaciones Médicas A. Lanari (UBA)
09.2012 - 06.2016

Project Intern

Ministerio De Agricultura. Dirección De Pueblos Originarios
09.2012 - 06.2016

Escuela Agrotécnica - undefined

Escuela Agrotécnica 717

Maestría - Ciencia Tecnología y Sociedad

UNQUI

Licenciatura - Biotecnología

UNSAM

Associate of Applied Science - Clinical Trials Monitor

FEFyM
Ayelén Rapoport