Carlos Montefusco Pereira-Toxicology & Risk Assessment Consultant
Check rate
Experience
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.
AI in Risk Assessment Intern
InSilicoVida
- Develop AI/ML workflows supporting toxicology and exposure risk modeling for decision support
- Create and improve processes
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
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%
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
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
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
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Pharmaceutical, Biotechnology, Food and Beverage, Government and Administration, Education, and Healthcare.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Research and Development, Operations, Product Development, and 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
Education
WBS Coding School
Data Science & AI Program · Data Science & AI · Berlin, Germany
Saarland University
PhD Pharmaceutical Technology · Pharmaceutical Technology · Saarbrücken, Germany
University of Lincoln; University of Cordoba; Egas Moniz University
MSc Forensic Sciences · Forensic Sciences · United Kingdom
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Carlos is based in Berlin, Germany.
Carlos speaks the following languages: Portuguese (Native), English (Advanced), Spanish (Advanced), German (Intermediate).
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 11 months. Note that Carlos may not have shared all experience and actually has more experience.
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.
Carlos's most recent position is Toxicology & Risk Assessment Consultant at European Food Safety Authority.
In recent years, Carlos has worked for European Food Safety Authority, InSilicoVida, BioNTech SE, and Boehringer Ingelheim.
Carlos is most experienced in industries like Pharmaceutical, Biotechnology, and Food and Beverage. Carlos also has some experience in Government and Administration, Education, and Healthcare.
Carlos is most experienced in business areas like Quality Assurance, Research and Development, and Product Development. Carlos also has some experience in Operations and Project Management.
Carlos has recently worked in industries like Biotechnology, Pharmaceutical, and Food and Beverage.
Carlos has recently worked in business areas like Quality Assurance, Research and Development, and Operations.
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.
The availability of Carlos needs to be confirmed.
Daily rate distribution
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Average rates for similar positions
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 30 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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