Raquel Carvallo
Director of Research Development @博士伦
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WORK HISTORY
Director of Research Development @博士伦
US
Lead a high-performing team in developing, optimizing, and scaling manufacturing processes for B&L sterile pharmaceutical portfolio - emphasizing eyecare products, injectables, and biologics- Covering early- to late-stage development, ensuring robust, scalable, and cost-effective processes that adhere to regulatory standards (FDA, EMA, ICH) and cGMP compliance- Influence the R&D organization, ensuring that technology transfers, risk management, and process improvements are executed with precision.
EDUCATION
Universidad Simón Bolívar
Master of Science in Chemical Engineering, Multiphase Flow, Transport Phenomena
Universidad Nacional Experimental Politécnica 'Antonio José de Sucre'
Bachelor of Science, Chemical Engineering, Water Treatment
University of South Florida
Master of Chemical Engineering, Heat transfer, Mass transfer, Thermodynamics,Drug delivery, sustained modulation.
University of South Florida
PhD in Chemical Engineering, Micro-encapsulation, Endothermic and Exothermic reactions
SKILLS
ABOUT RAQUEL CARVALLO
A seasoned and versatile Chemical Engineer (PhD, M.C.H.E, M.S.C.E), with 18Y pharmaceutical experience on new product development, process improvements, scale up and technology transfers; including Softgels/LFHS/LIB/Transdermal/OSD, controlled substances, hormones, otic and ophthalmic sterile manufacturing. Strong background on product management from early stage to commercial, and CMC filing. Capable of successfully handling multiple projects/customers and meeting aggressive timelines. Experienced self-motivated team builder, with goal-driven personality. Solid communication and planning skills. Fluent in English, Spanish, and Portuguese. Following are bottom line accomplishments: • 18Y SME on Healthcare & Pharmaceutical Development for: sterile products, oral dosage, solutions, suspensions, emulsions, ointments, semi-solids, animal health products. • Experience working supporting multi-country teams on Drug Product Development and Tech Transfers.• Key SME responsible for launching 12 NDA/ANDA/ANADA/VMS/OTC products within 20••••24.• Successfully leading directly, a team of 15+ highly trained professionals and indirect support to a team of 100+PD/ARD team, and 100+ customer projects.• Strong record of operational management and strategic leadership in a Matrix organization, aligning customer needs and PD/ARD/QC /OPS resources to consecutively meet PD/PM/BD/Site goals of 45Millions for FY22 and FY23.• Currently supporting implementation of GMP/Non-GMP Pilot Plant and equipment qualification. • Co-Implemented harmonization project with Global QA/Regulatory CMC RI and Company DMF.• Conducted training on best manufacturing practices for 30 FDA reviewers.• Generated Validation Strategies, PV protocols and Master Batch Records• Aseptic gowning certified• Patents (WO2007/087039),(WO/2010/053467) and US79•••09.• Dual Citizenship US/Italy, fluent in English, Spanish and Portuguese.Specialties: MS & T, Strategic Leadership Pilot Plant Product Development Technical Transfer Softgel development/manufacturing Operational Management Problem Solving and Decision Making Scale up FMEA Change Control SOPs RCA/CAPA CMC OTC ANDA NDA ANADA VMS.
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