Gustavo Elicker Coelho Email & Phone Number

Brazil

Joinville, Santa Catarina, Brazil

-Developing and validating innovative analytical methodologies for pharmaceuticals, adhering to guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), World Health Organization (WHO), and Brazilian Health Regulatory Agency (Anvisa).-Leading the advancement and validation of analytical methods using HPLC/UPLC, GC, KF, UV, and FT-IR technologies.-Undertake technical investigations and devise strategies to tackle challenges in the early development stages.-Compose and critique technical documents for regulatory submissions, ensuring alignment with global standards and enhancing communication with regulatory bodies.-Specialise in formulating and validating analytical methods for herbal drugs and products, showcasing a deep understanding of phytochemical analysis.-Enhance the robustness and reliability of analytical methods through optimisation, validation, and transfer by regulatory requirements.-Conduct thorough analytical data gathering, interpretation, and compound characterisation, ensuring precise documentation for regulatory review.-Extensive knowledge in method development and validation, validation/qualification, and transfer challenges.-Expertise in laboratory practices and adherence to Good Manufacturing Practices (GMP), leading investigations and designing projects or equipment.-Analyse Active Pharmaceutical Ingredients (APIs), raw materials, and excipients with various analytical techniques.Achievements: -Optimised analytical methods for pharmaceuticals, significantly reducing costs, analysis time, and solvent use.-Implemented structured documentation for the R&D department, including templates and technical justifications.-Developed and validated over 15 analytical methods for both herbal and synthetic medications.-Authored a technical evaluation to obtain an exemption from the performance method specified in the pharmacopeial monograph.

Joinville Area, Brazil

-Conducted research and developed new analytical methods for identifying, quantifying, and qualifying ingredients in dietary supplements.-Optimised existing analytical methodologies to improve efficiency, accuracy, and compliance with international standards.-Collaborated with the quality control department to ensure all dietary supplements meet regulatory requirements set forth by Anvisa, FCC, and WHO.-Prepared and reviewed technical documents, including method development reports, validation protocols, and standard operating procedures (SOPs).-Stayed up-to-date with advancements in analytical techniques and regulatory changes to ensure our methodologies were current and compliant.-Assisted in the training of laboratory personnel on new methods and technologies.-Collaborated with cross-functional teams, including product development, regulatory affairs, and quality assurance, to facilitate the successful launch of new products.-Participated in internal and external audits related to the analytical methods developed.

Joinville, Santa Catarina, Brazil

- Delivered classes for Thermodynamics.- Module covered: Thermodynamics.

Joinville, Santa Catarina, Brazil

-Delivered classes for Thermodynamics and Chemical Reaction Engineering modules-Modules covered: Thermodynamics, Chemical Reaction Engineering

Joinville Area, Brazil

- Developed catalytic microreactor operating with ethanol for propulsion application

Joinville, Santa Catarina, Brazil

Master'S Degree, Engineering And Mechanical Sciences

Bachelor Of Engineering - Be, Erasmus In Chemical Engineering And Management Subjects, Erasmus

Relevant coursework: - Research Challenges in Materials Science - Safety and Industry - Project Management Theory and Practice.

Bachelor Of Engineering - Be, Chemical Engineering