Lucas Arnoldi Email & Phone Number

Rio De Janeiro, Brazil

Rio De Janeiro, Brazil

- Responsible for implementing, maintaining and managing the Quality Management System (QMS) in a new pilot plant for the production of immunobiological products for clinical trials;- Designing and compliance with the Validation Master Plan and Annual Qualification, Calibration and Preventive Maintenance Plan for analytical and production equipment;- Analysis of proposals and technical specifications for contracts and engineering projects;- Management of outsourced services and negotiation of qualification, calibration and maintenance contracts for equipment and machines;- Preparation and revision of SOPs related to activities carried out in the areas;- R&D in scale-up of the manufacturing process for recombinant vaccines;- Responsible for providing training on current Good Manufacturing and Laboratory Practices (cGMP/cGLP) and Quality Assurance overall.

Rio De Janeiro, Brazil

- Responsible for the Periodic Product Review (PPR) process for the Haleon manufacturing site (formerly GSK Consumer Healthcare);- Presentation of two continuous improvement projects for the PPR process awarded in two editions of Haleon's INOVE/HAPS program;- Conducting the development of an intern in the PPR process;- Direct interaction with health inspectors from regulatory bodies;- Gap assessments in legislation and policies of the PPR process.

Rio De Janeiro, Brazil

Support and active role in the process of obtaining the initial manufacturing licenses for the new company Haleon (GSK Consumer Healthcare spin-off);- Participation in GMP regulatory inspection control room for Medicines, Medical Devices and Cosmetics;- Interaction with inspectors and preparation of high-level presentations;- Conducting Housekeeping and Data Integrity Gembas in production and support areas aimed at inspection readiness;- Support in the migration of IT systems and documents to the new company.

Rio De Janeiro, Brazil

- Support and elaboration of Periodic Product Review (PPR) reports, according to local and international regulatory agencies requirements and in accordance with the principles of Data Integrity (DI);- Support the preparation and reception of regulatory inspections, corporate GMP audits and internal audits, by carrying out Gembas in production areas, audit control room participation and support, gathering relevant GxP documentation and performing inspection readiness actions; - Development of Dashboards (in Power BI) to assist the management and automation of PPR, Internal Audit, Access Control to Production Systems, CPV/PLM and CAPA processes; - Management support in increasing the following KPIs: Operator Production Equipment Training Compliance, PPR Lead Time, and PPR Right First Time; - Compilation and updating of the Site Master Plant (SMF) together with the corresponding areas;- Assist local and global policy/legislation gap analysis relevant to the Periodic Product Review process;- Support and elaboration of computerized systems validation (CSV) documentation;- Support the management of the department's deliverables, such as CAPAs, Audits, Validations, Change Controls, Action Items, etc).

Rio De Janeiro, Brazil

Responsible for 3 classes of heat transfer, where I was able to improve my communication and assertiveness skills through:- Creation of PowerPoint presentations and reports;- Application of Excel to chemical processes;- Live broadcasts and recording of classes;- Preparation and correction of exercise lists;- Study group leadership.

Rio De Janeiro, Brazil

- Supporting the implementation of quality and sustainability certifications, in addition to the ESG and CSR agendas;- Applying monthly audits, in addition to developing and monitoring action plans for root cause identification and analysis, and treatment of non-conformities related to products and processes;- Supporting the design of quality, performance and operational cost reduction KPIs for the sector;- Process mapping through Swimlane Diagram, in order to guarantee and monitor the quality and continuous improvement of work methodologies;- Opening calls, monitor the implementation and write off the quality control of services provided in the quality management system (QMS) based on continuous improvement tools (PDCA, LSS, 5S) and QEHS standards.

Rio De Janeiro, Brazil

- R&D of the production process of recombinant proteins in animal cell cultures for a new recombinant subunit vaccine for COVID-19;- Transfection and selection of stable recombinant animal cells;- Study of purification and characterization techniques of virus-like particles (VLPs) and recombinant proteins, focusing on HPLC, Immunoblot and SDS-PAGE;- Study of methodologies for measuring cellular immune response and clinical test formats and designs; - Preparation of databases in Excel and results presentations in PowerPoint.- Project awarded with an honorable mention at the 11th Academic Integration Week at UFRJ;

Chemical Engineering Doctorate, Biotechnological Processes, 2.8/3.0

Integrated Masters Degree In Chemical And Biochemical Process Engineering, Biosystems And Bioproducts Engineering, 2.9/3.0

Chemical Engineering Bsc, Biopharmaceuticals, 8.8/10.0