2016 OMB Summer Meeting

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Herbalife International of America, Inc.. Sep. 2010-present
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. March 2009-Sep. 2010
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 , 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, H1 and C13 NMR, and x-ray diffraction.
Quanyin Gao
AOAC OMB Meeting Book 195