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Marcelo B. R&D Analytical and Nitrosamines ConsultantMB

Marcelo B.

R&D Analytical and Nitrosamines Consultant
1 recommendation
  • Suggested rate
    €550 / day
  • Experience15+ years
  • Response rate100%
  • Response time1 hour
The project will begin once you accept Marcelo's quote.
Location and workplace preferences
Location
Mogi das Cruzes, Brazil
Remote only
Primarily works remotely
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Skill set
Industry fields of expertise
Pharmaceuticals
Chemicals
Marcelo in a few words
My academic journey began early, at the age of 16, quickly followed by Master's and Doctoral degrees. My professional entry point was a pharmaceutical laboratory, in the captivating field of Organic Synthesis. Today, I celebrate over 25 years dedicated to Analytical Chemistry within R&D, a path built on passion and continuous learning.

Throughout this rich experience in the pharmaceutical industry, I've developed a robust and multifaceted analytical expertise. Leading development and validation projects (always with a keen eye on Good Laboratory Practices), navigating the complex regulatory landscapes of ANVISA and global authorities, and implementing effective quality systems have become my specializations. Nitrosamines risk assessment, mastery of cutting-edge analytical techniques, and managing challenging projects are tools I use with proficiency. I believe in the power of strategic thinking and the pursuit of creative problem-solving, always aiming to optimize operations.

Now, driven by the desire to share the knowledge that has blossomed throughout this journey, I present myself as a freelance business partner. Empathy is the compass guiding my interactions, and the pursuit of results that exceed expectations is my driving force.
Experience
  • Oxiteno (Indorama)
    R&D Analytical Development Laboratory Coordinator
    CHEMICAL
    January 2023 - June 2024 (1 year and 5 months)
    Mauá, Brazil
    As a leader in analytical lab management, I have strong experience in team leadership, people management, and budget/investment control. My project management and strategic decision-making skills drive organizational goals, operational excellence, and team development, ensuring lab success.

    My professional career in the pharmaceutical industry was marked by solid experience in improving quality standards in accordance with Good Manufacturing Practice (GMP), and based on this experience, I improved the Quality standards (GLP) in the R&D Oxiteno Laboratory, by enhancing traceability, logbooks, document flow, approvals, training, materials management, and 5S application, strengthening quality culture and efficiency.

    I facilitated communication with suppliers, securing free in-company training, and built strategic partnerships with Agilent, Sciex (Chromatography/LC-MS), and Mettler Toledo (DSC/TGA), boosting team capabilities and lab productivity.

    I optimized lab analytics with advanced Excel, developing KPIs and tracking for analytical programming, increasing team performance. A purchasing spreadsheet linked spending to budget, improving financial control.

    In the R&D Digital Committee, I promoted digital culture, creating newsletters (Sway), and implementing SharePoint/Workplace. I use AI tools (ChatGPT-4, Copilot) to enhance performance, knowledge, and digital initiatives.
  • Sanofi (BR)
    Chemist II
    PHARMACEUTICALS INDUSTRY
    September 2008 - June 2014 (5 years and 9 months)
    Suzano, Brazil
    Analytst, and after, as Leader of analytical subgroup, working on the Development and Validation of analytical methods by HPLC, GC and Dissolution, with a focus on the development of analytical methods indicative of stability, for the analysis of dosage, related substances, residual solvents.

    Development and validation of residual cleaning analytical methods.

    DMF evaluation of raw material/active substance suppliers.

    Coordination and Support on the New Product Stability Studies.

    Organic chemistry consultancy for the Galenic Laboratory and Regulatory team.

    ESH representative in the analytical department.
  • Sanofi (BR)
    Analytical Development Laboratory Coordinator
    PHARMACEUTICALS INDUSTRY
    June 2014 - December 2022 (8 years and 6 months)
    Suzano, Brazil
    Project Management and Analytical Laboratory: Led analytical development and validation projects (drug registration compliance). Managed the Analytical Laboratory (documentation review/approval, tech innovation, regulatory focus). Excelled in team leadership/development (new software, improved methods).

    Team development and leadership: Managed a 12-member team (hiring, growth). Introduced QbD/DOE software (MODDE®, FUSION™) for method/formulation improvement. Implemented Action Stat® (method validation - ANVISA RDC 166/17) and BIOSTAT (dissolution/shelf-life).

    Global Projects: Actively participated in global Data Integrity and Nitrosamines projects (leadership, collaboration). Significantly contributed to building Sanofi's new CHC analytical lab (project management, technical execution).

    Regulatory Affairs: Led strategic assessment/improvement of regulatory dossiers (ANVISA). Expertise in CTD preparation (international regulations). Key role in defining analytical strategies for ANVISA, challenging norms with scientific insights.

    Quality: Strong in quality (gap analysis, non-conformity/CAPA leadership, document review/approval). Quality Focal Point for global Data Integrity implementation in R&D.

    Nitrosamines and Emerging Skills: Direct involvement in the consolidation of knowledge on new technical requirements. Conducted the Risk Assessment for all Suzano Development projects and participated in the global Nitrosamines Risk Assessment committee (evaluating all Sanofi products at risk). Also developed expertise in Extractables and Leachables to meet ANVISA and international regulatory requirements.

    Stability Studies: Responsible for new product stability studies (protocol development, test/criteria definition - regulatory standards). Crucial in reviewing/approving stability reports for ANVISA and other submissions.
1 recommendation
RC

Rafaela Chaia recommend Marcelo

Rafaela ChaiaRC
Rafaela Chaia
Sanofi
4/22/2025
I had the pleasure of working with Marcelo during several years on projects involving R&D analytical strategy and nitrosamine risk assessments. His deep expertise in analytical method development & validation, regulatory compliance, and nitrosamine control was invaluable. He consistently delivered high-quality work, communicated clearly, and demonstrated a proactive, solution-oriented mindset throughout the collaboration.
I highly recommend Marcelo for any organization seeking a reliable and knowledgeable partner in pharmaceutical R&D and nitrosamine consultancy!
Education
  • Doctorate in Organic Chemistry
    USP (Institute of Chemistry)
    2001
    PhD in Organic Chemistry
  • Bacharel in Chemistry
    USP (Institute of Chemistry)
    1993
    Graduation