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To Provide Expert Training and Consulting in HPLC
and Pharmaceutical Analysis

Michael Dong, Ph.D.

Michael is a subject matter expert in HPLC and pharmaceutical analysis with 20+years of experience in HPLC and pharmaceutical development (CMC analytical team lead).

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Michael pioneered Fast

LC, generic methods for stability-indicating assays, residual solvents, and cleaning verification.  He advocated a three-pronged template approach for HPLC method development in early-phase new drug development.

SNAPSHOT
  • Ph.D. Analytical Chemistry
    (City U. of New York Graduate Center)

     

  • MWD Consulting (8y),
    Genentech (8y),

    Purdue Pharma (6 y),
    Perkin-Elmer (19 y)

     

  • Authored 4 HPLC books and 130+ publications,
    LCGC columnist since 2013

     

  • Presented 130 training courses in HPLC and pharmaceutical analysis
     

  • ACS Career Consultant
    (3 y), Toastmasters (10 y),  Multilingual (Chinese).

SERVICES
  • Training in HPLC/UHPLC, pharmaceutical analysis, regulations, and drug quality

    - In-depth pharmaceutical, GMP, and instrumentation industry experience.

     

  • Consulting services in HPLC, method development, small-molecule CMC, and pharmaceutical analysis 

    - Expertise in stability-indicating HPLC, UHPLC and LC/MS methods  

Education: High school, College, Graduate School, and Biotech Cerificate

I went to Diocesan Boys' School in Hong Kong for 7 years, and then came to America to Brooklyn College in New York City and obtained a B.S. in Chemistry, followed by Graduate School at the City University of New York Graduate Center for a Ph.D. in Analytical Chemistry.  Many years later, I supplemented my knowledge in Biotechnology with a certificate at U. California Santa Cruz Extension in 2010.

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Four Full Time Jobs
 
After graduate school, I post-doc for one year at the Naylor Dana Institute in cancer research and then joined Celanese Research Co. in New Jersey as a research chemist (section head of separations group). I then relocated to Connecticut as a Sr. Applications Chemist in liquid chromatography with Perkin-Elmer, followed by a transition to pharmaceutical research at Purdue Pharma, a short stint as a research director with an CRO, and then 8 years as a Sr. Scientist with Genentech in California.  I relocated back to Connecticut and became an independent consultant in 2015.
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Four Books and a Memoir

I wrote 4 books starting with the 'red book' in Fast LC in 1981, a handbook in pharm analysis by HPLC, Elsevier, in 2005, and two editions of 'HPLC for practicing scientists" with Wiley in 2006 and 2019.  The last two books were bestsellers in HPLC typically ranked  #1 or #2 in Google searches on HPLC books. I wrote my memoir during the pandemic and self-published in KDP.
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Bestseller HPLC book
Published ~130 technical papers (90+ as the first author)

I am a disciplined and prolific writer of technical papers and published 130+ journal articles on chromatography and pharm analysis.  I am a columnist for LCGC North America since 2013 with four articles on "Perspectives in Modern HPLC" each year.  Most of the installments are 'white papers' aiming to be educational overviews on HPLC, MS, and pharm analysis applications.
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Presented 130+ short courses in HPLC and pharm analysis at Pittcon, ACS, EAS, and HPLC.  Taught drug quality at UCSC Extension.

Since 2001, I have been giving short courses on HPLC and pharm analysis at National Conferences annually at Pittcon, EAS, ACS and HPLC. I also taught workshops or courses in organizations such as Separation Science, PBSS Bay Area, AAPS, and UCSC extension.  I often give onsite training courses for private clients such as pharm companies (Gilead, Ocular Therapeutics, Norwich Pharms, Recro Pharma), and other non-profit organizations (USP, City of Hope, East Carolina U., Chrom. Forum Delaware Valley).
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