Dr. Lucas Sá
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Lucas Sá
- Bis heute 6 Jahre und 11 Monate, seit Juni 2019
CMC Project Manager
Myelo Therapeutics GmbH
- Project Management (planning, execution and monitoring) of API and Drug Product projects. - Knowledge of global regulatory legislation: FDA and EMEA. - Management of API and Drug Product CMOs and partner networks. - Elaboration of API and Drug Product (CTD modules 2 and 3) documentation. - Review of Nonclinical and Clinical Trials documentation.
- 1 Jahr und 3 Monate, Jan. 2018 - März 2019
Senior Scientist Drug Product/Formulation Development
FQM
- Planning and executing development of pharmaceutical formulations using concepts of QbD and DoE. - Scale-up from lab to industrial scale, troubleshooting and process optimization. - Technology transfer. - Elaboration of development protocols and reports for submission. - Pre-formulation and Stability studies. - Physicochemical characterization of API and DP (DSC, TGA, DRX, FTIR, DLS, etc.). - Regulatory legislation: EMEA, FDA, ICH, ANVISA, GMP. - Scrum management.
- 3 Jahre und 6 Monate, Aug. 2014 - Jan. 2018
Scientist Drug Product/Formulation Development
Farmanguinhos/Fiocruz
- Planning and executing development of pharmaceutical formulations using concepts of QbD and DoE. - Studies of compression physics/properties with Fette Galenic software. - Scale-up from lab to industrial scale. - Tech transfer. - Elaboration of development protocols and reports. - Pre-formulation and Stability studies. - Physicochemical characterization of API and DP. - Regulatory legislation: EMEA, FDA, ICH, ANVISA, GMP, ISO 9001. - International partnership participation.
- 3 Jahre, Aug. 2009 - Juli 2012
Quality and Development Consultant
Força da Terra
- Development of cosmetic formulations. - GMP implementation. - Technical documentation management. - Regulatory legislation: ANVISA. - Training application.
- 1 Jahr und 7 Monate, Feb. 2007 - Aug. 2008
Internship
Farmoquímica (FQM)
- Execution of all stages of process validation. - Equipment qualification. - Elaboration and compilation of validation and qualification documentation. - Process statistical control. - Monitoring of manufacturing of liquids, including injectables, solids and semi-solids formulations. - Quality Compliance.
Ausbildung von Lucas Sá
- 6 Monate, Aug. 2013 - Jan. 2014
Specialization’s in Pharmaceutical Industrial Technologies
Farmanguinhos/Fiocruz
- 5 Jahre, Aug. 2012 - Juli 2017
Ph.D Polymer's Science and Technology
Macromolecules Institute Professor Eloisa Mano / UFRJ
“Synthesis and characterization of PBS grafted with PVAc, preparation and characterization of particles loaded with ibuprofen for pharmaceutical application”. Development of polymeric materials and pharma. application. Physical/Chemical characterization and pharma. properties analysis.
- 2 Jahre und 1 Monat, März 2010 - März 2012
Master's in chemistry
Pontifical Catholic of Rio de Janeiro
“Synthesis, characterization and evaluation of drug delivery systems based in mesoporous silica for image in nuclear medicine”. Development of radiopharmaceuticals/Drug Delivery Systems. In vivo Scintigraphy tests. Physical/Chemical characterization.
- 5 Jahre und 3 Monate, März 2004 - Mai 2009
Pharmaceutical Sciences
Federal University of Rio de Janeiro
Sprachen
Englisch
C1 (Fließend)
Spanisch
B1-B2 (Gute Kenntnisse)
Deutsch
A1-A2 (Grundkenntnisse)
Portugiesisch
C2 (Verhandlungssicher / Muttersprachlich)
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