R&D Bio Pharma Services Team Members
Raquel E. Dompenciel, PhD
raqueldompenciel@rdbps.com
Vice-president of R&D Bio Pharma Services, LLC. Over twenty years of experience in regulated industries of medical device and biopharmaceuticals in areas of technical support and quality. Held functions leading investigations of product, process, and analytical methods nonconformities. Developed visual inspection processes and training. Developed quality system processes such as Nonconformance, CAPA and Quality Risk Management. Led a site Quality Engineering organization with oversight to Quality System processes such as NC, CAPA, Change Control, Complaints, Annual Product Review, Quality Risk Management, Management Review, Validation and Process Monitoring.
Earned her Bachelor and Master degrees in Biology at the University of Puerto Rico, Rio Piedras. Her PhD in Molecular and Cell Biology at the University of Massachusetts, Amherst. Conducted Post-doctoral work in Biochemistry and Molecular Biology at the Department of Pharmacology, Uniformed Services University of the Health Sciences (USUHS) in Bethesda, MD. Has received several Amgen awards in Quality, Operations, Process Improvement, and product transfers.
Member of the Abbott Diagnostics’ Technical Advisory Board. Recipient of several academic awards such as Ford Foundation Postdoctoral Fellow, NIH Postdoctoral Traineeship, American Society for Cell Biology (ASCB), UMASS Graduate School Fellowship, UMASS Minority Scholar Fellowship and NIH Graduate Traineeship. Author of several publications in peer-reviewed journals. Member of the PDA Visual Inspection Forum.
President of R&D Bio Pharma Services, LLC. Over 27 years of experience in areas covering from basic scientific research to the manufacturing operations for drug substance, drug product, and medical devices. Areas of expertise and competencies include applied biochemical and engineering concepts in support of commercial scale microbial and mammalian cell culture, chromatography operations, drug product formulation, and characterization through analytical assays. As head of a Drug Substance Process Development department, oversaw the technical transfer of mammalian and microbial drug substance manufacturing processes, process qualifications, process monitoring, and process improvement programs aligned with the expectations of the regulatory agencies on continuous process verification.
Member a of Global networks on Drug Substance manufacturing and Product Quality Review. Earned his Bachelor and Master degrees in Biochemistry and Biochemical Toxicology at the University of Massachusetts, Amherst. Conducted Doctoral studies in Biochemistry at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, MD. Recipient of Amgen awards for Excellence in Operations, Process Improvements and Excellence in Science and Engineering, Member of the Abbott Diagnostics Technical Advisory Board, recipient of a UMASS Graduate School Fellowship and UMASS Minority Scholar Fellowship. Author of several peer-reviewed scientific publications.
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raqueldompenciel@rdbps.com
Vice-president of R&D Bio Pharma Services, LLC. Over twenty years of experience in regulated industries of medical device and biopharmaceuticals in areas of technical support and quality. Held functions leading investigations of product, process, and analytical methods nonconformities. Developed visual inspection processes and training. Developed quality system processes such as Nonconformance, CAPA and Quality Risk Management. Led a site Quality Engineering organization with oversight to Quality System processes such as NC, CAPA, Change Control, Complaints, Annual Product Review, Quality Risk Management, Management Review, Validation and Process Monitoring.
Earned her Bachelor and Master degrees in Biology at the University of Puerto Rico, Rio Piedras. Her PhD in Molecular and Cell Biology at the University of Massachusetts, Amherst. Conducted Post-doctoral work in Biochemistry and Molecular Biology at the Department of Pharmacology, Uniformed Services University of the Health Sciences (USUHS) in Bethesda, MD. Has received several Amgen awards in Quality, Operations, Process Improvement, and product transfers.
Member of the Abbott Diagnostics’ Technical Advisory Board. Recipient of several academic awards such as Ford Foundation Postdoctoral Fellow, NIH Postdoctoral Traineeship, American Society for Cell Biology (ASCB), UMASS Graduate School Fellowship, UMASS Minority Scholar Fellowship and NIH Graduate Traineeship. Author of several publications in peer-reviewed journals. Member of the PDA Visual Inspection Forum.
Jose Hector Rivera, MS
josehectorrivera@rdbps.com
josehectorrivera@rdbps.com
Member a of Global networks on Drug Substance manufacturing and Product Quality Review. Earned his Bachelor and Master degrees in Biochemistry and Biochemical Toxicology at the University of Massachusetts, Amherst. Conducted Doctoral studies in Biochemistry at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, MD. Recipient of Amgen awards for Excellence in Operations, Process Improvements and Excellence in Science and Engineering, Member of the Abbott Diagnostics Technical Advisory Board, recipient of a UMASS Graduate School Fellowship and UMASS Minority Scholar Fellowship. Author of several peer-reviewed scientific publications.
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