Carlos Montefusco pereira

Toxicology & Risk Assessment Consultant

Carlos Montefusco pereira
Berlin, Germany

Experience

Oct 2025 - Present
4 months

Toxicology & Risk Assessment Consultant

European Food Safety Authority

  • Conduct scientific evaluations and risk assessments for substances and materials with relevance to human health, including nanoparticle safety.
Oct 2025 - Present
4 months

AI in Risk Assessment Intern

InSilicoVida

  • Develop AI/ML workflows supporting toxicology and exposure risk modeling for decision support
  • Create and improve processes
Aug 2023 - Nov 2024
1 year 4 months
Germany

Staff Trainee in Clinical Pharmacology and Pharmacometrics

BioNTech SE

  • Designed a population PK model for mRNA-cytokines using mrgsolve and R for oncology applications
  • Developed anti-drug antibody (ADA) assay strategies across three clinical trials
  • Managed CRO deliverables, including model-based reports and exposure–response analyses to support Type B FDA meetings
Aug 2022 - Dec 2024
2 years 5 months
Germany

Functional Lead - Manager Good Clinical Practice Operations

BioNTech SE

  • Led GCP operations across 12 global trials, including strategic oversight of CMC and drug product operations for protein, peptide, cell, and mRNA-based therapies
  • Authored and reviewed CMC (in-use stability, pharmacy manuals) and clinical operations (risk detection, pharmacy questionnaires) documentation ensuring GxP readiness for regulatory audits by 100%
  • Acted as subject matter expert during inspection readiness and execution for RiboMabs and RiboCytokines
  • Supervised and developed a team of five clinical trial specialists, improving operational performance and compliance by 20%
Jun 2020 - May 2022
2 years
Germany

Scientist on In-Use Stability of New Biological Entities

Boehringer Ingelheim

  • Co-led the laboratory of in-use stability on new biological entities (NBEs)
  • Spearheaded cross-functional CMC strategy development and new process development using QbD, DoE, and ICH frameworks for early-to-late stage biologics
  • Managed 10 Phase I/II trials exploring administration routes including IV, SC, inhalation, and intravitreal
  • Oversaw regulatory meeting preparations and submission of IMPD/IND, BLA, and MAA dossiers aligned with CTD Module 3
  • Led a team of five technicians to achieve 90% timely trial startup through cross-functional collaboration
Oct 2019 - Jun 2020
9 months
Germany

Staff Scientist on Clinical Pharmacy and Pharmacometrics

Free University Berlin

  • Developed interactive analytics applications using Python, SQL, and Streamlit
  • Developed a PK/PD model assessing CYP2D6 metabolism using R, NONMEM, and Phoenix WinNonlin, reducing coefficient of variation by 96% with a new clinical covariate
  • Led trial simulations using optimal experimental design, reducing sampling timepoints by half
  • Conducted exploratory modeling to support microdosing strategies with yohimbine
Jul 2014 - Jan 2015
7 months
Switzerland

External Consultant and Pharmacist Intern

World Health Organization

  • Improved submission quality of analytical chemistry sections of CTD dossiers by 50% for WHO prequalification and the List of Essential Medicines
  • Advised on best practices in GMP compliance and dossier preparation

Summary

With experience spanning drug development, clinical research, regulatory and public-health consulting, pharmacometrics, and data science & AI.

Background across industry, global health institutions, and research settings, with hands-on involvement in CMC, clinical pharmacology, GCP operations, real-world data activities, and quantitative modeling.

Skills

Programming & Modeling

  • Python
  • R
  • Sql
  • Mrgsolve
  • Scikit-learn
  • Tensorflow
  • Langchain
  • Tableau
  • Docker

Cmc & Drug Development

  • Qbd
  • Ich Q8–q11
  • Doe
  • Ctd Module 3
  • Cross-functional Team Leadership
  • Risk-based Cmc Strategy

Clinical Trials & Operations

  • Gxp
  • Regulatory Submissions
  • Cdisc
  • Sdtm/adam
  • Phase I–iii Trial Management
  • Vendor Oversight

Soft Skills

  • Process Creation And Improvement
  • Active Listening
  • Problem-solving

Selected Projects & Portfolio

  • Real-world Data And Analytics (Openfda Api Ingestion, Rwe Clustering, Utilization And Safety Dashboards)
  • Data Products (Interactive Analytics Applications Using Python, Sql, And Streamlit)
  • Modeling And Simulation (Bioequivalence And Clinical Trial Simulations Using Optimal Experimental Design, Pumas.jl, Power And Sample-size Analysis)
  • Pharmacometrics And Ml (Exposure–response Modeling And Adc Platform Selection)
  • Ada And Immunogenicity (Regulatory-aligned Benchmarks, Bioanalytical Correction Concepts, And Reporting Frameworks)

Languages

Portuguese
Native
English
Advanced
Spanish
Advanced
German
Intermediate

Education

Mar 2025 - Apr 2026

WBS Coding School

Data Science & AI Program · Data Science & AI · Berlin, Germany

Sep 2015 - Feb 2020

Saarland University

PhD Pharmaceutical Technology · Pharmaceutical Technology · Saarbrücken, Germany

Sep 2012 - Jul 2014

University of Lincoln; University of Cordoba; Egas Moniz University

MSc Forensic Sciences · Forensic Sciences · United Kingdom

...and 1 more
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