Carlos Montefusco Pereira - Toxicology & Risk Assessment Consultant

Q: Where is Carlos based?

Carlos is based in Berlin, Germany .

Q: What languages does Carlos speak?

Carlos speaks the following languages: Portuguese (Native), English (Advanced), Spanish (Advanced), German (Intermediate) .

Q: How many years of experience does Carlos have?

Carlos has at least 6 years of experience. During this time, Carlos has worked in at least 7 different roles and for 6 different companies . The average length of individual experience is 1 year and 10 months . Note that Carlos may not have shared all experience and actually has more experience.

Q: What is Carlos's latest experience?

Carlos's most recent position is Toxicology & Risk Assessment Consultant at European Food Safety Authority .

Q: What companies has Carlos worked for in recent years?

In recent years, Carlos has worked for European Food Safety Authority , InSilicoVida , BioNTech SE , and Boehringer Ingelheim .

Q: Which industries is Carlos most experienced in?

Carlos is most experienced in industries like Pharmaceutical , Biotechnology , and Education . Carlos also has some experience in Healthcare , Food and Beverage , and Government and Public Administration .

Q: Which business areas is Carlos most experienced in?

Carlos is most experienced in business areas like Quality Assurance (QA) , Research and Development (R&D) , and Product Development . Carlos also has some experience in Operations and Project Management .

Q: Which industries has Carlos worked in recently?

Carlos has recently worked in industries like Biotechnology , Pharmaceutical , and Food and Beverage .

Q: Which business areas has Carlos worked in recently?

Carlos has recently worked in business areas like Quality Assurance (QA) , Research and Development (R&D) , and Operations .

Recommended expert

Berlin, Germany

Experience

Oct 2025 - Present

5 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

5 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

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (5.5 years), Biotechnology (4.5 years), Food and Beverage (0.5 years), Government and Administration (0.5 years), Education (0.5 years), and Healthcare (0.5 years).

Pharmaceutical

Biotechnology

Food and Beverage

Government and Administration

Education

Healthcare

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (5 years), Research and Development (4 years), Operations (2.5 years), Product Development (2.5 years), and Project Management (1.5 years).

Quality Assurance

Research and Development

Operations

Product Development

Project Management

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

Profile

Created

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Carlos based?

Carlos is based in Berlin, Germany.

What languages does Carlos speak?

Carlos speaks the following languages: Portuguese (Native), English (Advanced), Spanish (Advanced), German (Intermediate).

How many years of experience does Carlos have?

Carlos has at least 6 years of experience. During this time, Carlos has worked in at least 7 different roles and for 6 different companies. The average length of individual experience is 1 year and 10 months. Note that Carlos may not have shared all experience and actually has more experience.

What roles would Carlos be best suited for?

Based on recent experience, Carlos would be well-suited for roles such as: Toxicology & Risk Assessment Consultant, AI in Risk Assessment Intern, Staff Trainee in Clinical Pharmacology and Pharmacometrics.

What is Carlos's latest experience?

Carlos's most recent position is Toxicology & Risk Assessment Consultant at European Food Safety Authority.

What companies has Carlos worked for in recent years?

In recent years, Carlos has worked for European Food Safety Authority, InSilicoVida, BioNTech SE, and Boehringer Ingelheim.

Which industries is Carlos most experienced in?

Carlos is most experienced in industries like Pharmaceutical, Biotechnology, and Education. Carlos also has some experience in Healthcare, Food and Beverage, and Government and Public Administration.

Which business areas is Carlos most experienced in?

Carlos is most experienced in business areas like Quality Assurance (QA), Research and Development (R&D), and Product Development. Carlos also has some experience in Operations and Project Management.

Which industries has Carlos worked in recently?

Carlos has recently worked in industries like Biotechnology, Pharmaceutical, and Food and Beverage.

Which business areas has Carlos worked in recently?

Carlos has recently worked in business areas like Quality Assurance (QA), Research and Development (R&D), and Operations.

What is Carlos's education?

Carlos holds a Doctorate in Pharmaceutical Technology from Saarland University, a Master in Forensic Sciences from University of Lincoln; University of Cordoba; Egas Moniz University, a Bachelor in Data Science & AI from WBS Coding School and a Bachelor in Pharmacy and Biochemistry from Paulista University.

What is the availability of Carlos?

Carlos will be available full-time from April 2026.

What is the rate of Carlos?

Carlos's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.