A Bit About Me
I am a skillful, detailed-oriented, and creative Research Scientist with a combination of knowledge, expertise, and talents for conducting detailed and complex investigations within analytical, matrixed, laboratory, and pharmaceutical environments. My 14+ year history encompasses the design of experiments, engineering of research processes, development, validation, and transfer of analytical methods, development of pharmaceutical products, and the management of projects, quality, and various scientific data.
My degrees, coupled with my publications, and many years of professional work, have ensured that I can appropriately utilize my expertise and knowledge to publish journal articles in peer-reviewed journals, foster industry collaborations, drive the successful execution of research experiments, and ensure the incorporation of several scientific and R&D tools to generate results.
In addition to that, I am also adept at supervising, managing, and leading multidisciplinary and multicultural teams. Talented at interfacing with persons at various industry research levels, delivering comprehensive data analysis, and streamlining operations, I am capable of not only generating solutions to research problems but also achieving and surpassing all targeted goals.
Over the course of my career, I have provided efficient instruction to students, researchers, and cross-functional professionals, displayed a deep passion for various areas of pharmaceutical sciences, and showcased exceptional capabilities during collaborations with research and academic-industry leaders.
I am proud to serve as an Innovation Specialist at EMBRAPII, where I play a pivotal role in advancing cutting-edge projects within the realm of pharmaceutical sciences. It is my passion to drive innovation and contribute to the growth of the pharmaceutical industry, making a lasting impact on the field.
By going through my profile, it will be easy to see that I have outstanding proficiencies in:
• Cutting Edge Research
• Process Engineering
• Pharmaceutical Research Studies
• Quality, Project, & Risk Management
• Assay Development
• Grant Proposal Writing
• Product Development & Integration
• Research & Development
These various attributes will ensure that I, not only, have the understanding to independently execute research investigations but also drive overall understanding of various pharmaceutical concepts and research techniques to obtain and deliver product goals.
Education
Doctor of Philosophy (Ph.D.), Materials Engineering and Technology
PUCRS - Pontifícia Universidade Católica do Rio Grande do Sul 2012 - 2016
Title: Study of C. roseus Extraction and Production of Nanoparticles for Vinblastine Release
Advisor: Dr. Eduardo Cassel
Master’s Degree, Materials Engineering and Technology
PUCRS - Pontifícia Universidade Católica do Rio Grande do Sul 2010 - 2012
Title: Study of Antimicrobial Activity of Essential Oil of Lemongrass and its Fractions for Body Care Products
Advisor: Dr. Eduardo Cassel
Bachelor of Science (B.S.), Pharmaceutical Sciences
PUCRS - Pontifícia Universidade Católica do Rio Grande do Sul 2006 - 2010
Work Experience
Industrial Innovation Specialist
at EMBRAPII - Empresa Brasileira de Pesquisa e Inovação Industrial 2023 - Present
I play a role in advancing cutting-edge projects within the pharmaceutical sciences. My work focuses on providing crucial technical support to EMBRAPII units engaged in diverse initiatives, including drug discovery, vaccine development, drug delivery systems, pre-clinical trials, and clinical trials. In addition, I audit their projects, ensuring adherence to the highest standards of quality and innovation.
• Carry out evaluations and audits of processes in EMBRAPII Units and in other groups of interest in its strategic actions.
• Periodically monitor the activities and results of the evaluated institutions using the information systems and specific computer tools developed by EMBRAPII.
• Technically review and issue opinions on action plans and other documents relevant to the accreditation of research groups.
• Elaborate and review processes, norms, and participate in the planning processes of EMBRAPII.
Postdoctoral Scientist
at Universidade de Brasília 2022 - 2023
Developed and tested in vitro and ex vivo methods to evaluate the performance and effectiveness of ophthalmic and dermatological drug delivery systems. Gaining a better understanding of drug product performance and improved the efficiency of drug product development. Additionally, designed and validated bioanalytical methods for drug quantification in complex biological matrices. Furthermore, collaborated on cross-functional projects with a large team of scientists, contributing to the scientific community.• Developed and tested in vitro and ex vivo methods to evaluate the performance and effectiveness of ophthalmic drug products, leading to an improved understanding of drug product performance and more efficient drug product development.
• Developed and validated bioanalytical methods for drug quantification in complex biological matrices, resulting in accurate and reliable measurement of drug concentrations for drug penetration studies.
• Designed and tested drug delivery systems, such as nanoparticles, nanocapsules, lipid-based nanoparticles, and gels, to enhance drug efficacy and reduce side effects. Resulting in a published paper entitled "In Vitro Performance Analysis of a Minoxidil Thermosensitive Gel with Reduced Runoff for Eyebrow Hair Growth", contributing to the field of drug delivery systems.
• Designed and modeled prototypes in Autodesk Fusion 360 for 3D printing, enabling rapid prototyping and iterative design improvements.
• Proposed and implemented innovative experimental designs and concepts to advance core group/research objectives, showcasing expert knowledge and creativity.
• Collaborated on 6 cross-functional projects with a large team of scientists and engineers to advance drug discovery and development.
• Demonstrated leadership and mentorship skills by supervising postgraduate and graduate-level researchers and providing training in laboratory techniques and safety protocols.
Career Break 2021 - 2023
During my career break, I pursued personal and professional development opportunities while taking time to reflect on my career goals. I obtained membership from American Association of Pharmaceutical Scientists (AAPS) and continued to research and strategize pharmaceutical sciences articles to stay up-to-date on industry developments. In addition, I traveled to South America, Brazil, and the United States, gaining new cultural perspectives and experiences. I focused on my health and wellness goals by completing a fitness program and participating in a mindfulness program, which has improved my overall well-being.
Senior Analytical R&D Analyst
at União Química Farmacêutica Nacional 2019 - 2021
Implemented strategies to develop and assess analytical methods in alignment with Validation Master Plan (VMP), accompanying documentation, and regulatory requirements. Relayed and conveyed project status to team across multiple platforms, while maintaining plans via Microsoft Projects. Established validation parameters, aligned with business objectives and regulatory criteria. Enforced compliant status and oversaw timely delivery of methodologies. Tracked and reviewed documentation surrounding products, raw materials, as well as test methods to implement methodologies. Created compendial updates and maintained research plans.
• Ensured the achievement of all strategic, business, and regulatory standards by supporting project plans, conducting quality data analysis, troubleshooting all issues identified, and validating results.
• Independently communicated research findings through the preparation of clear technical reports, publications, and oral presentations, effectively conveying updates to senior management within the context of project goals.
• While serving as an Analytical Method Validation Team Leader, timely developed and validated a collection of methods while simultaneously maintaining compliance with the Validation Master Plan (VMP).
• Within a one-year span, led a cross-functional team of Analysts through the initiation, execution, and completion of 323 analytical method validations.
• Served as a resource and technical leader both within and outside the department in a specific project-relevant area or technology, offering guidance and expertise to drive the progress of R&D projects and assess new technologies and concepts.
• Achieved the regulatory approval of 20 new generic products after creating and validating analytical methods as well as performing forced degradation studies to prepare reliable scientific data.
Senior Analytical R&D Analyst, Stability Testing
at União Química Farmacêutica Nacional 2017 - 2019
Conducted trends analysis and follow-up studies on Out of Specification (OOS) Investigations in adherence with Corrective and Preventative Actions (CAPA). Oversaw and implemented project structures to ensure compliance with predefined timelines, quality standards, and budgets. Collaborated with regulatory, manufacturing, and quality assurance divisions to ensure achievement of stipulated objectives. Reviewed vendor proposals. Performed array of complex validation testing for clinical and toxicological studies utilizing raw materials and active pharmaceutical ingredients, as well as wet chemical, physical, and instrumental techniques. Conceptualized, developed, and applied research skills to perform complex, routine, and non-routine chemical tests and assays on active pharmaceutical ingredients as well as in-process and finished products.
• Promoted from an R&D Analyst – Stability Testing to a Senior R&D Analyst after displaying outstanding leadership and project management• Met quality, budget, and time-specific goals for each assigned project by building and maintaining collaborative relationships with vendors and Quality, Regulatory, and Manufacturing groups.
• While serving as the R&D department focal point for data integrity, led, planned, and supported all activities that were related to the implementation and maintenance of effective quality laboratory systems.
• As an R&D stability testing team lead, provided oversight of the execution of stability studies for more than 200 products.
• Successfully spearheaded R&D non-conformance investigations and prepared Corrective and Preventive Actions (CAPA’s) when necessary to ensure the prevention of reoccurring problems.
• Managed a 25-member team, comprised of R&D Analysts, that were responsible for performing more than 1500 accelerated, long-term, photostability, and in-use stability studies for drug products and active pharmaceutical ingredients (API).
Analytical R&D Analyst, Stability Testing
at União Química Farmacêutica Nacional 2016 - 2017
• Conceptualized, developed, and applied research skills to perform complex, routine, and non-routine chemical tests and assays on active pharmaceutical ingredients as well as in-process and finished products.
• Demonstrated a broad knowledge base within the field of expertise, including the ability to interpret current literature and apply it to relevant R&D projects.
• Prepared accurate and precise data for samples used in stability, raw material, clinical and toxicological studies using a wide range of validated and compendial analytical procedures and analytical instrumentation.
• Assisted the development of 10 new products by supervising stability projects for early prototypes and process optimization as per ANVISA/ICH guidelines.
• Following the identification of problem areas, utilized scientific resources to not only recommend alternatives but also priorities areas, and generate solutions to resolve issues.
• Maintained proper records in accordance with Standard Operating Procedures (SOPs) and organizational policies to support documentation and traceability.
Doctoral Researcher
at PUCRS - Pontifícia Universidade Católica do Rio Grande do Sul 2012 - 2016
Enhanced extraction and purification of vinblastine using Supercritical Fluid Extraction and established innovative drug delivery system. Analyzed and reviewed proposals for project development while implementing parameters such as technical feasibility, accuracy, cost, and market analysis. Managed and updated project progress reports for grant renewal purposes.
• Developed and implemented analytical project strategies, created and validated analytical test methods, designed separation techniques, and employed effective sample testing protocols to ensure proper collection, assessment, and interpretation of data.
• Generated reports, notes, and proposals that outlined methods performed, project development phases, problems identified, suggestions presented, and solutions rendered.
• Served as a Trainer and Mentor; demonstrated leadership by supervising postgraduate and graduate-level researchers.
• Accelerated the delivery of critical breakthroughs and achieved a positive impact on project outcomes after evaluating external literature to identify and evaluate areas of innovation.
• Aided in the acquisition of more than USD $172K in subsidies after comprehensively writing several grants proposals and managing research projects, resulting in grant renewals.
• Improved projects to ensure technical feasibility, accuracy, cost, and market analysis.
• Initiated, executed, and completed a project that developed an innovative drug delivery system after creating and optimizing innovative drug delivery prototypes which were later published in the Journal of Polymeric Materials and Polymeric Biomaterials.
• Optimized the extraction and purification of vinblastine using Supercritical Fluids, which was submitted and published in the journal of Supercritical Fluids.
• Demonstrated success in working independently and as part of a large cross-functional team resulting in 9 publications, 6 collaborative projects, and 4 scholarships.
Visiting Graduate Researcher
at UCLA - University of California, Los Angeles 2014 - 2015
Synthesized glycopolymers via ATRP and RAFT techniques, leding to the development of hybrid glycopolymer-PLGA nanoparticles for vinblastine delivery. Provided valuable technical support, resulting in a collaborative paper, contributing to advancing the frontiers of drug delivery technology and the scientific community.
• Not only synthesized and polymerized glycomonomers but also produced a drug delivery systems after creating hypotheses, implementing experimental plans, and polymerizing glycopolymers (via ATRP and RAFT).
• Prepared detailed notes, proposals, weekly progress reports, and monthly presentations which were all later presented to the research group and publications in peer-reviewed journals.
• Designed, developed, and characterized hybrid glycopolymer-PLGA nanoparticles for vinblastine delivery resulting in one training grant.
• Demonstrated effective teamwork by giving technical support to colleagues resulting in a collaborative paper.
• Successfully published a research investigation entitled Lipid-polymer hybrid nanoparticles as a targeted drug delivery system for melanoma treatment.
Visiting Graduate Researcher
at Universidad de la República 2012
Excelled in developing and scaling analytical methods and high-throughput assays for molecule selection in product development. I also managed data analysis, reporting, and conducted experiments evaluating essential oils, deterrent, anthelmintic, and insecticidal activities. Published two impactful papers, demonstrating a commitment to advancing research and development.
• Developed, streamlined, and scaled not only analytical methods but also high throughput assays to identify the right molecule and prioritize its placement with the desired properties to enable product development.
• Collected and analyzed data before interpreting and generating reports that outline research findings.
• Performed a collection of experiments to determine the deterrent activity (against Epilachna paenulata and Pseudoletia adultera), anthelmintic activity (against Nippostrogylus brasilensis), and the insecticidal activity (against Rhipicephalus microplus and Haematobia irritans) of several essential oils.
• Successfully achieved a renewal of an annual grant after routinely submitting update reports to university/research stakeholders.• Initiated, executed, completed, and published two papers entitled:
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Impact of gas chromatography-mass spectrometry combined with gas chromatography-olfactometry for Baccharis articulata sex differentiation by the analysis of volatile compounds.
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Empleo de la cromatografía de gases olfatometria (GC-O) para el análisis de volátiles de Baccharis articulata y Baccharis dracunculifolia (Asteraceae).
Graduate Student Researcher
at PUCRS - Pontifícia Universidade Católica do Rio Grande do Sul 2010 - 2012
Determined possible areas of innovation by conducting exhaustive literature review. Examined fractionation of lemongrass essential oil through utilization of vacuum distillation harboring antimicrobial fraction. Implemented separation methodologies to enable isolation and purification of terpenes of essential oils. Facilitated technology transfers between university and external stakeholder. Conducted analytical method development, validation, and testing of chemical and microbiological stability.
• Managed and supported the development of formulas, analytical characterization of diverse molecules, technical transfer of scientific information, and the constant compliance with USP, industry, and federal standards.
• Generated reports, notes, and proposals that outlined methods performed, project development phases, problems identified, suggestions presented, and solutions rendered.
• Accelerated the delivery of critical breakthroughs and achieved a positive impact on project outcomes after evaluating external literature to identify and evaluate areas of innovation.
• Initiated, executed, and completed two projects that developed a cost-effective triclosan/paraben-free body care product line. Resulting in two commercially available. Working from the essential oil extraction to industrial production of six body care products.
• Designed and implemented separations methods that enabled the isolation and purification of terpenes from essential oils.
• Used Vacuum distillation techniques to not only examine the fractionation of lemongrass essential oil but also obtain an antimicrobial fraction that was later selected for commercial use.
Pharmacist
at Dermogral 2011 - 2012
• While, temporarily, working in solid, semi-solid, and homeopathic formulation laboratories, scheduled and performed quality control of active pharmaceutical ingredients (API) and raw material in accordance with Standard Operating Procedures (SOPs).
• Received and stored incoming supplies, eliminated outdated and damaged drugs, monitored inventory dates, and recorded shortages to guarantee accurate stock regulation within the compounding pharmacy quality control laboratory.
• Partner with professional colleagues, peers, and other cross-functional personnel to guarantee adherence with best industry practices, state guidelines, and federal drug regulations.
Publications
Barbalho, GN; Falcão, MA; Amaral, VA; Contarato, JLA; Cunha-Filho, M; Gelfuso, GM; Gratieri, T. Hydrogel-based hybrid membrane enhances in vitro drug evaluation in OphthalMimic device. Methods, Volume 230, October 2024, Pages 21-31 (https://doi.org/10.1016/j.ymeth.2024.07.010)
Barbalho, GN; Falcão, MA; Amaral, VA; Contarato, JLA; Cunha-Filho, M; Gelfuso, GM; Gratieri, T. OphthalMimic: a new alternative apparatus without animal tissue for the evaluation of topical ophthalmic drug products. Methods, Volume 228, August 2024, Pages 1-11 (https://doi.org/10.1016/j.ymeth.2024.05.005)
Barbalho, GN; Falcão, MA; Lopes, JMS; Lopes, JM; Contarato, JLA; Cunha-Filho, M; Gelfuso, GM; Gratieri, T. Dynamic Ex Vivo Porcine Eye Model to Measure Ophthalmic Drug Penetration under Simulated Lacrimal Flow. Pharmaceutics, v. 15(9), p. 2325, 2023. (https://doi.org/10.3390/pharmaceutics15092325)
Xavier, LC; Matos, BN; Barbalho, GN; Falcão, MA; Cunha-Filho, M; Gelfuso, GM; Gratieri, T. In Vitro Performance Analysis of a Minoxidil Thermosensitive Gel with Reduced Runoff for Eyebrow Hair Growth. Gels, v. 9(4), p. 269, 2023. (https://doi.org/10.3390/gels9040269)
Scopel, R; Falcão, MA; Cappellari, Ar; Morrone, FB; Guterres, SS; Cassel, E; Kasko, AM; Vargas, RMF. Lipid-polymer hybrid nanoparticles as a targeted drug delivery system for melanoma treatment. Int J Polym Mater, v. 71(2), p. 127-138, 2022. (https://doi.org/10.1080/00914037.2020.1809406)
Falcão,MA; Scopel, R; Almeida, RN; Do Espirito Santo, AT; Franceschini, G; Garcez, JJ; Vargas, RMF; Cassel, E. Supercritical fluid extraction of vinblastine from Catharanthus roseus. J Supercrit. Fluids, v. 129, p. 9-15, 2017. (https://doi.org/10.1016/j.supflu.2017.03.018)
Minteguiaga, M; Umpiérrez, N; Fariña, L; Falcão, MA.; Xavier, VB; Cassel, E; Dellacassa, E. Impact of gas chromatography and mass spectrometry combined with gas chromatography and olfactometry for the sex differentiation of by the analysis of volatile compounds. J. Sep. Sci. (Print), v. 38, p. 3038-3046, 2015. (https://doi.org/10.1002/jssc.201500131)
Scopel,R; Falcão, MA; Lucas, AM; Almeida, RN ; Gandolfi, PHK; Cassel, E; Vargas, RMF. Supercritical Fluid Extraction from Syzygium aromaticum Buds: Phase Equilibrium, Mathematical Modeling and Antimicrobial Activity. J Supercrit. Fluids, v. 92, p. 223-230, 2014. (https://doi.org/10.1016/j.supflu.2014.06.003)
Scopel, R; Neto, RG; Falcão, MA; Cassel, E; Vargas, RMF. Supercritical CO2 Extraction of Schinus molle L with Co-Solvents: Mathematical Modeling and Antimicrobial Applications. Braz Arch Biol Technol (Printed), v. 56, p. 513-519, 2013.
Vargas, RMF; Barroso, MST; Neto, RG; Scopel, R; Falcão, MA; Silva, CF; Cassel, E. Natural products obtained by subcritical and supercritical fluid extraction from Achyrocline satureioides (Lam) D.C. using CO2. Ind Crops Prod (Print), v. 50, p. 430-435, 2013.
Sartor, T.; Xavier, VB, Falcão, MA; Mondin, CA; Dos Santos, MA; Cassel, E; Astarita, LV; Santarém, ER. Seasonal changes in phenolic compounds and in the biological activities of Baccharis dentata (Vell.) G.M. Barroso. Ind Crops Prod (Print), v. 51, p. 355-359, 2013.
Fianco, ALB; Falcão, MA; Cassel, E; Milão, D. Determination of the antimicrobial activity and total polyphenol content of ethanolic extracts of propolis from stingless bees Tetragonisca angustula (Jataí) and Scaptotrigona bipunctata (Tubuna). Liberato Magazine (Novo Hamburgo), v. 14, p. 21-28, 20
Falcão, MA; Fianco, ALB; Lucas, AM; Pereira, MAA; Torres, FC Vargas, RMF; Cassel, E. Determination of antibacterial activity of vacuum distillation fractions of lemongrass essential oil. Phytochem Rev (Print), v. 11, p. 405-412, 2012.
Intellectual Properties
Falcão, MA; Barbalho, GN, Cunha-Filho, M; Gelfuso, GM; Gratieri, T.Hybrid Hydrogel-Based Films and its Use for In Vitro Evaluation of Ophthalmic Formulations Performance and Incorporating Reconstructed Human Cornea for Permeation Assessment. Intellectual Property - Patent, BR1020240146409, 2024
Falcão, MA; Cunha-Filho, M; Gelfuso, GM; Gratieri, T. Ophthalmic Performance Test Device Configuration. Intellectual Propriety - Industrial Design, BR3020230051546, 2023.
Projects
Development of an in vitro model and device for ophthalmic drug product performance evaluation
(2022 - 2023)
Associated with Universidade de Brasília (UnB)
The regulatory requirements for ophthalmic formulations registration, generic or similar, oblige that the formulations have the same viscosity as a guarantee of the same performance. If the formulations do not have the same viscosity, which is very common, there are no in vitro methodologies to prove dynamic performance. Thus, this biotechnology project was created out of a need from the pharmaceutical industry demand. This project covers two completely innovative proposals, from its design and conception, of alternative methods to the use of animals for evaluating the performance of ophthalmic formulations during the research and development stages with a view to future use for regulatory purposes. They are the ex vivo Whole Eye Globe model with simulated tear flow and the OphthalMimic model, completely artificial for evaluating the dynamic performance of formulations. Initially, such models would be used in the research and development stages for comparisons between formulations, without an in vitro/in vivo correlation being possible.
Development of extraction processes and antineoplastic controlled release systems in supercritical environment
(2014-2016)
Associated with Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS) and University of California, Los Angeles (UCLA)
Development of supercritical fluid extraction processes and antineoplastic controlled release systems, research based on the use of supercritical carbon dioxide in the pharmaceutical production chain, from the extraction of an antineoplastic drug (vinblastine) from plants to the processing and fabrication of polymeric films nanoimpregnated with therapeutic agents for controlled release. The project aimed to incorporate engineering knowledge into the processes of natural products supercritical fluids extraction, the production of polymeric nanosystems impregnated with antineoplastic drugs, and the study of in vitro controlled release kinetics.
Development of Biopesticides by plant extracts nanoimpregnation in biopolymers
(2012-2016)
Associated with Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Optimization of biopesticides through the impregnation of bioactive botanical and/or fungal extracts in biopolymers. The extracts were selected from previous research projects results of the participating groups (LOPE – Brazil and CSIC – Spain). The selected biopolymers are modified natural polymers: chitosan cross-linked with glutaraldehyde, gelatin cross-linked with formaldehyde, and cellulose transformed into cellulose acetate.
Development of extraction processes and evaluation of the aromatic and medicinal potential of Mercosur native Baccharis species
(2012-2016)
Associated with Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS) and Universidad de la Republica (UdelaR)
Development of South American native plant resources through the sustainable use of the genus Baccharis, with a focus on the search for extracts with commercialization potential. This project involves the systematic chemical study of plants of the genus Baccharis from the native flora identified at the Center for Research and Conservation of Nature Pró-Mata (CPCN Pró-Mata) of the Pontifícia Universidade Católica do Rio Grande do Sul, the technological development of productive processes, extracts natural products, rigorous quality control of the products obtained and a study of applications of the extracts obtained.
Modeling and Simulation of Essential Oils Process Production by Steam Distillation: Mass and Energy Balance
(2011-2016)
Associated with Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Simulation and mathematical modeling of the steam distillation essential oil extraction process, using energy and mass balance with the objective of generating subsidies for a better relationship between the modeling and the results obtained in the industrial process. Since the mathematical simulation of an extractive process is a fundamental step for the implementation of processes at an industrial level with adequate and efficient characteristics, this project intends to estimate parameters from laboratory extractions (laboratory and pilot-scale), unavailable in the scientific literature.
Development of natural antimicrobial agents for use in body care products: essential oils and its fractions
(2010-2012)
Associated with Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Study of the use of essential oils and their respective fractions obtained by vacuum distillation as natural antimicrobial agents for the development of body care products. Evaluate the influence of essential oils and their respective fractions composition on the antimicrobial activity against the microorganisms Salmonella choleraesuis, Pseudomonas aeruginosa, and Staphylococcus aureus, using qualitative and quantitative microbiological techniques. The essential oils selected for studies were lemongrass (Cymbopogon citratus), citronella (Cymbopogon winterianus) and Baccharis dracunculifolia.