2016 OMB Summer Meeting

AOAC OMB Meeting Book

195

Quanyin Gao

Sep. 2010-present

Herbalife International of America, Inc..

Director ， Quality Control  Laboratory management on quality control of RM & FP release and stability sample testing.  Laboratory compliance management for dietary supplement and functional food products.  Formulation and manufacturing process characterization analysis.  Method development and validation for botanical identification, assay, and limit test.  Facilitated audits by FDA, NSF, Kosher, HACCP, and Halal without lab observations. Irvine Pharmaceutical Services, Inc. Director ， Analytical Development  Managed multiple CRO/CMO projects to meet goals timely such as bioanalytical and formulation development; structure analysis; compendial testing; method development and validation.  Drug substance and drug product quality control release and stability tests.  Impurity profiling of small molecules and biopolymers.  Injectable and lyophilized product formulation and process development. Watson Pharmaceuticals, Inc. (Corona, CA) Associate Director, R&D July 2004-Feb. 2009 Manager, R&D July 2001-June 2004 Supervisor, R&D August1999-June 2001  Successfully developed 24 generic solid dosage form drug products for ANDA filings and drug substance DMF.  Extensive experience with FDA’s QbD, QbR, QOS and related regulatory requirements for ANDAs or amendments to ensure the product CMC.  Obtained FDA approvals for critical products for commercialization including first to file and Paragraph IV filing. Responded deficiency letters to obtain product approvals.  Facilitated Watson’s Corona, China, and Poteau Rico sites cGMP auditing by FDA. Interacted with FDA inspectors during pre-approval cGMP auditing with no 483 observation.  Managed four teams of about 30+ R&D scientists with B.Sc. M.Sc, and PhD with high standard of performance. Mentored lab staff for their technical and career growth.  Acquired, qualified and applied modern instrumentation for solid dosage form and inhalation product development using LC/MS, GC/MS, IR, UV/Vis, Fluorescence, Andersen Cascade Impactor (ACI), Next Generation Impactor (NGI), particle size analysis by Malvern Mastersizer, hot stage microscope, DSC, TGA, SEM, chemical imagining NIR, XRD, and Raman. Braun/McGaw Medical Inc. (Irvine, CA) Senior Staff Scientist, Pharmaceutical Development June1997- August 1999  Filed NDAs for parental drug products with drug substance/drug product development, method validation and method transfer.  Investigated leachables/extractables of parenteral plastic containers using SPE, GC, HPLC, LC/MS/MS, LC/ELSD, GC/MS, GC/FTIR, H 1 and C 13 NMR, and x-ray diffraction. March 2009-Sep. 2010

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