Navigation überspringen

Dr. Lucas Sá

Angestellt, CMC Project Manager, Myelo Therapeutics GmbH
Berlin, Deutschland

Fähigkeiten und Kenntnisse

MS Office
Research
Product Development
Characterization (materials science)
Pharmaceutical industry
Pharmaceuticals
Quality by Design
Design of Experiment DOE
Pharmaceutical Formulation
Polymers
GMP
English Language

Werdegang

Berufserfahrung von Lucas Sá

  • Bis heute 6 Jahre, 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

    Fließend

  • Spanisch

    Gut

  • Deutsch

    Grundlagen

  • Portugiesisch

    Muttersprache

XING – Das Jobs-Netzwerk

  • Über eine Million Jobs

    Entdecke mit XING genau den Job, der wirklich zu Dir passt.

  • Persönliche Job-Angebote

    Lass Dich finden von Arbeitgebern und über 20.000 Recruiter·innen.

  • 22 Mio. Mitglieder

    Knüpf neue Kontakte und erhalte Impulse für ein besseres Job-Leben.

  • Kostenlos profitieren

    Schon als Basis-Mitglied kannst Du Deine Job-Suche deutlich optimieren.

21 Mio. XING Mitglieder, von A bis Z