I am Amilcar, and I am a biotechnology pharmaceutical professional in quality and process development with 7+ years of experience. Just like some people are amused by improvements in electronics and space exploration, my passion is to endeavor for biotechnology improvements in pharmaceuticals. I am proud to be part of the movement for developing both therapies and therapeutic manufacturing (cGMPs) processes for treatments of historic human health problems as efficiently as possible while still meeting high-quality standards. Process development in pharmaceuticals can take years, but when you enjoy your job, enjoy working with people you work with, and know that the work is for a good cause of humanity, you become highly motivated to work on these challenging projects. If you share a similar passion, send me a message and let us connect. SELECTED KNOWLEDGE & SKILL AREASKnowledge Areas: cGMP • Standard Operating Procedures (SOP) • Lean Process Improvement • Technical Writing • Team Building & Leadership • Research • Coaching & Mentoring • Problem Solving • Data Analysis • Risk Management • Code of Federal Regulations (CFR) Title 21 • United States Pharmacopeia (USP) • Quality Systems Regulation (QSR) • Analytical Methods • Corrective Action Preventive Action (CAPA) • Root Cause Analysis • Good Laboratory Practices (GLP)Technical Skills: MS Office Suite • Minitab • HMI
Amgen/Aditi Consulting
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Pivotal Process Development Associate ScientistAmgen/Aditi Consulting Dec 2021 - PresentSupported the pharmaceutical drug product/substance process development. • Trained weekly to meet the needs of the research procedures and certification requirements. • Executed/maintained/standardized/troubleshot a lyophilizers, Karel Fisher, HPLC (SEC), rCE, HIAC, MFI, viscometer, pH meter, and other laboratory equipment to analyze the characteristics/stability/robustness of a DS/DP on a weekly basis while being pH meter power user. • Authored/reviewed/verified technical protocols/documents to assure they meet Good Documentation Practices (GDP) to prepare them for further steps in the process development such as process execution or commercialization. • Maintained proper 5S laboratory environments while collaborating with colleagues in multidisciplinary teams.
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Manufacturing Technician IiGrifols 2019 - 2021Supported the manufacturing of biopharmaceuticals/therapeutics in highly regulated and cleanroom environments. Followed Standard Operating Procedures (SOPs), Good Documentation Practices (GDPs), complied with Food and Drug Administration (FDA)/ European Medicines Evaluation Agency (EMEA)/ current Good Manufacturing Practices (cGMPs) regulatory requirements.• Trained experienced manufacturing technicians on equipment operations, compliance within a cGMP facility, and sample testing. • Performed routine documentation to record the material balance, production yields, and any procedure completed throughout the day according to regulatory requirements to maintain a record of the full operation.• Took various raw material samples to analyze quality, prevent errors/defects within processes and laboratory equipment.• Analyzed the pH, conductivity, turbidity, took product samples, and conducted titrations to maintain quality control of the product. -
Manufacturing Technician IGrifols 2016 - 2019Los Angeles, California, United States• Led a laboratory/production analysis standardization project to improve the plasma fractionation process. Employed technical writing skills to standardize and reduce steps within sample titrations, procedures, and manufacturing equipment to help maximize efficiency for product yields. Produced a technical report as a central deliverable for upper management and recommendations were widely adopted within department. • Trained/led over 15+ entry level manufacturing technicians on production SOPs, cGMPs, technical documentation, sanitation processes, and product harvesting. Contributed to increased productivity within Fractionation Department.• Deployed 5S principles in maintaining optimal organization of 20+ cleanrooms within production floor.• Lifted, push, pulled, and carried equipment up to 50 pounds in loud/cold/wet/cleanroom environments which required special gowning to meet the operational needs in the facility.
Amilcar Santos Education Details
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3.95 Gpa -
Environmental Science
Frequently Asked Questions about Amilcar Santos
What company does Amilcar Santos work for?
Amilcar Santos works for Amgen/aditi Consulting
What is Amilcar Santos's role at the current company?
Amilcar Santos's current role is QA/QC Specialist – I help biopharmaceutical organizations develop their process in both manufacturing and drug product development. | Quality Assurance | Quality Control | cGMP | Pharma|.
What schools did Amilcar Santos attend?
Amilcar Santos attended Azusa Pacific University, University Of California, Riverside.
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