Experience

• 

  Enterey Life Sciences Consulting

  • Irvine, CA

  • Senior Audit Consultant

    • Aug 2014 - Present
    • Irvine, CA

    Sr. Consultant at Enterey Life Sciences conducting Quality System GMP Compliance on-site audits for clients' vendors/suppliers located in Europe, Asia, North America and Australia. .

• 

  XOMA

  • Berkeley

  • Sr. Consultant- Quality Manager

    • Jan 2015 - Jun 2015
    • Berkeley

    Sr. Consultant in the Quality department performing review of the Quality Systems Oversight Activities. Leading Pre-approval for readiness effort for the Corporation by reviewing and recommending improvements to quality operational policies, plans and procedures. Review deviations, CAPA, Change Controls procedures, audit/inspection reports, protocols, test methods, validation reports and SOPs. Notify Sr. Management of potential quality or regulatory issues that may impact product quality and or regulatory compliance. Lead meetings and provide guidance on best practices to execute consistent, reproducible and compliant systems.

• 

  Hospira

  • Lake Forest, ILL

  • Consultant

    • Feb 2013 - Dec 2014
    • Lake Forest, ILL

    Project Lead managing a staff of 25 Chemists conducting gap assessment and remediation of analytical test methods for APIs and drug substance/released products for US and global marketed products.

• 

  Validant Inc.

  • San Francisco Bay Area

  • Consultant

    • Aug 2011 - Nov 2011
    • San Francisco Bay Area

    Perform assessment of laboratory analytical GMP data used to support regulatory filings for evidence of aberrant results and investigations. Perform review and assessment of Research and Development laboratory analytical notebooks, electronic data and data packages. Review method development and stability data for non-investigated out-of-trend results. Document investigations in formal reports and Initiate retrospective Laboratory Investigation Reports.

• 

  Watson Pharmaceuticals

  • Corona, California

  • Supervisor

    • 2007 - 2010
    • Corona, California

    Supervised a staff 19 analytical chemists in the Hydro group, scheduling the testing and sequential release of finished and stability products.• Validated and transferred HPLC test methods used for in house and outside laboratories testing of Finished Products, stability and non-routine studies.• Used Operational Excellence Managerial tools in the Laboratory to reduce Finished Products testing cycle time by 50% in one-year period.• Used Trackwise software for electronic management of Laboratory investigations, deviations and to update SOPs, test methods and protocols through established change control procedures.• Conducted laboratory investigations, wrote Laboratory Reports (LIRs), and deviations to address OOS, OOT and aberrant results.• Tracked Finished Products and stability samples in LIMS to ensure products were tested and released on time.• Managed the supply of chemicals, reagents, lab supplies and laboratory high pressure gases for the Hydro and Microbiology testing groups, ensuring adequate supplies as indicated by internal 5S (sort, straighten, sanitize, standardize, and sustain) program.

• 

  Irvine Pharmaceutical Services

  • Irvine, Ca

  • Senior Research Scientist / Group Leader

    • Feb 2005 - Aug 2007
    • Irvine, Ca

    Managed technical and application scientists to develop, validate and qualify various test methods for the company’s clients.

• 

  Allergan, Inc

  • Irvine

  • Professional Biologist

    • 2002 - 2005
    • Irvine

    Member of a research group that conducted various biological studies to identify the target molecule for neuropathic pain.Generated rabbit polyclonal antibodies specific to the Alpha 2 B Adrenergic receptor and used them to identify the target organs for neuropathic pain.Constructed G protein-coupled receptor expression library by transduction and transfection of cell lines with orphan receptors and retroviral particles, leading to new drug discovery.Performed immunohistochemistry and immunocytochemistry on drg, spinal cord, brain, kidney, and liver tissues that detected specific proteins (CGRP, Sub. P, Trk B, VR1).

• 

  Beckman Coulter

  • Fullerton, CA

  • Research Scientist

    • 2001 - 2002
    • Fullerton, CA

    Member of a research group that developed MDQ capillary electrophoresis methods. Analyzed antibody-oligonucleotide conjugates by capillary electrophoresis (CE), resulting in the development of new CE methods for separation of denatured protein mixtures.Prepared specially printed DNA-micro array plates for ELISA-like multiplexed cytokine assays that were used as the platform for the A-squared technology.Performed fluorescence-based ELISA-like assays to detect proteins.

• 

  Childrens Hospital of Orange County (CHOC)

  • Orange, CA

  • Research Associate

    • 1995 - 2001
    • Orange, CA

    Member of the Hematology and Oncology Research department, conducting research in childhood lymphoma biology.Developed primers and polymerase chain reactions to study the rearrangement of c-myc and immunoglobulin genes in Burkett's patient samples and related cell lines so as to better understand the role of specific oncogenes and tumor suppressor genes in tumorgenicity in a wide range of children’s cancers.Designed semi-quantitative PCR assay to detect minimal residual Burkett's lymphoma cell contamination in a peripheral blood stem model, leading to better treatment for these patients.Performed gene sequencing to generate in-house colony, and inserted gene promoter into cell lines via transfection, transformation, and ligation to develop animal models for further research and discovery studies.