Marcella H.

Experience

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  Brazilian Pharmacopoeia

  Mar 2010 - Sept 2013

  Analyst

  • Performed quality control tests related to the development and characterization of new Pharmacopoeia Standards using a wide variety of analytical instrumentation from current Pharmacopoeia. • Produced project progress reports.• Managed and controlled risks related to the projects.• Participated in coordinating with all associated laboratories.• Recruited, trained, and supervised trainees.

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  Federal University of Rio Grande do Sul

  Apr 2010 - May 2014

  Researcher Ph.D

  • Tracked the project changes, budget, and timeline through excel sheet and Microsoft word• Planned and performed the entire project related to development, validation and pharmacokinetic studies (Clinical Trials) always trying to have the best strategy to stay on budget, time and quality of the project• Published the research results in three articles in internationally recognized journals

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  Ultraair

  Apr 2014 - Sept 2014

  Registered Pharmacist

  • Quality Assurance • Supplier qualification • Document control • Elaboration and reviewing of SOP’s• Certifications obtainment• Staff training

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  Kley Hertz Pharmaceutica S.A.

  Sept 2014 - Jan 2018

  Analytical Method Development Analyst

  • Elaborated, reviewed, and approved technical writing documents related to projects and regulatory guidelines• Performed scientific research for the investigation of non-compliant results and worked with a team to troubleshoot and problem solve• Led cross-functional team meetings as a Subject Matter Expert• Managed and executed tests related to process validation and test method transfers providing training and technical support to QC and stability analysts during method transferability• Worked with R&D and Regulatory Affairs teams regarding submission for test method changes or replacement. Provided response to regulatory requirements made by the Brazilian Regulatory Agency Show less

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  EMS (Vita Nova Institute)

  Jul 2018 - Mar 2019

  Analytical Development Scientist

  • Worked as a subject matter expert, liaising with the Contract Manufacturing Organization that produced an injectable peptide (complex generic) developed by Ems to launch in the US market, covering all phases since patent analysis, API, formulation and analytical development, pilot batches manufacturing, and dossier preparation for FDA submission• Elaborated Microsoft Project presentations for project meetings and scientific findings presentations• Organized, elaborated and reviewed technical documentation related to SOPs, method development, method validation, formulation development, and stability studies performed by CMOs according to ICH to be sent to the FDA (Product development meeting)• Participated in team meetings (both face-to-face and internacional video conferences) always seeking the best strategy to solve project issues and to maintain the projects on time, budget and scope Show less

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  ARA - Avanti Rx Analytics Inc

  Oct 2019 - May 2020

  Quality Control Chemist

  • Development and validation methods for medical cannabis products and raw material according to GMP requirements• Elaboration and revision of technical documentation related to method validation• Controlled reference standard Coordinator• Participation on Stability studies of medical Cannabis

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  Apotex Pharmachem Inc.

  May 2020 - Dec 2022

  Project Coordinator II, Technology Transfer

  • Facilitated process implementation by managing the delivery of milestones and related operational activities• Planned, executed, monitored and closed projects related to Technology Transfer involving multi-disciplinary teams from Canada and other countries• Prepared and reviewed key documentation, including technology transfer packages, equivalence reports and technical communication • Reviewed process description and other documentation to support Drug Master File submission at global markets Show less

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  Apotex Inc.

  Dec 2022 - Nov 2023

  Project Leader, Global R&D API Technical

  • Management of New Source Qualification Projects for APIs for Global Markets• Ensured that project milestone tracker was initiated, maintained and adhered to, for successful and timely execution of drug substance projects that have been assigned for internal development• Worked in conjunction with GAPI Supply Chain Management, tracked and ensured that internal or external suppliers of API were supporting product launch plans• Facilitated with cross functional teams and ensured that prioritization of proposed PLCM projects was understood by all involved and that projects were completed in a timely manner Show less