Eric Hanesana

Senior Director, Quality Assurance @Aspen Neuroscience, Inc

San Diego, CA, US
MOBILE NUMBERS
+18•••••••31

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WORK HISTORY

Sep 2023 — Present

Senior Director, Quality Assurance @Aspen Neuroscience, Inc

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San Diego, CA, US

EDUCATION

2017 — 2019

University of Maryland Global Campus

Master of Science - M.S., Biotechnology Regulatory Affairs

N/A

UC San Diego

Bachelor of Science (BS), Human Biology

SKILLS

LaboratoryDrug DevelopmentBioanalysisBiopharmaceuticalsStem Cell TechnologyGlpClinical TrialsElisaMonoclonal AntibodiesImmunologyAssay DevelopmentClinical ResearchCapaQuality SystemTissue CultureAnalytical ChemistryIch GuidelinesBiotechnologyStem CellsClinical MonitoringPipettingOutlookCell CultureCROHuman BiologyIsoPharmaceutical IndustrySopFdaImmunoassaysTechnology TransferBiomarkersClean RoomsAseptic TechniqueAseptic ProcessingMicrosoft WordQuality ControlValidationGmpClinical Development

ABOUT ERIC HANESANA

Eric is an ASQ-Certified Pharmaceutical GMP Professional (CPGP) and seasoned Quality professional with a Master\'s Degree in Biotechnology with Specialization in Regulatory Affairs. Possessing broad practical knowledge of the US, EP, and ROW regulations for drugs, biologics, and medical devices, Eric acquired key expertise around facility and cleanroom commissioning, qualification, and validation (CQV) and has developed and implemented robust, compliant GMP systems supporting all phases of the drug product life cycle. Honing his abilities as a problem solver, diplomatic leader and tactician, Eric leads numerous QA and QC teams with demonstrated effectiveness and high performance. His key strengths include regulatory affairs and quality audits, change management, implementing adaptive quality management systems, QC assay development, tech transfer, mammalian cell culture, aseptic techniques, environmental monitoring, microbiology, contamination control strategy (CCS), supply chain, and CRO/CDMO management. Eric\'s multidisciplinary skill set and proven track record makes him an MVP asset to any pharmaceutical quality organization.

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