Michael Zhou

Seeking for New Opportunities in Analytical / BioAnalytical R&D and Commercialization

Location
Raleigh-Durham, North Carolina Area
Industry
Pharmaceuticals
Current
  1. Lachman Consulting Services Inc.
Previous
  1. Quality System & Compliance (QSC), Inc.,
  2. Pars Pharmaceutical Consulting,
  3. Forest Laboratories, Inc.
Education
  1. University of Wisconsin-Madison
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Background

Summary

Accomplished Lead Scientist with analytical and bio-analytical R&D experience (small and large molecules) in support of drug/product R&D and commercialization programs; Functional and professional expertise areas include:
• Managed budget, strategic planning, recruiting, and other cross-functional activities in analytical and bioanalytical programs.
• Coached, trained, and led senior staff for multifunctional programs (in-vitro and in-vivo DMPK) and analysis.
• Provided technical and scientific expertise and guidance to ensure timely deliverables, resource allocation, and quality and integrity of data for management assessment and decision-making processes.
• Interacted with multi-functional program or project managers to meet company goals.
• Participated actively in global activities within scientific and regulatory societies and bodies for the enhancement of life sciences.
• Responsible for business and market development to realize CRO revenue to meet department / company goals
• Managed projects and programs from preclinical, clinical to manufacturing processes in support of different dosage forms (solid, liquids, injectable, etc.) product R&D and manufacturing along with quality systems (GxPs)
• Prepared documents (sections for INDs, NDAs / ANDAs and regulatory compliance) for preclinical / clinical & CMC programs.
• Responsible for research and project management for new drug / product development; analytical/bio-analytical methods development and validations for the determinations of drugs/CPPs in different matrices using LC, GC, CE, SDS-Page, SEC, GPC, UV-VIS, IR, NMR, LC-MS/MS and GC-MS/MS.
• Performed and supervised the projects and programs for analytical method transfer, quality control and manufacturing processes
• Executed facility and instrument qualifications (IQ/OQ/PQ) and software validation and CAPA implementations
• Good knowledge of global regulations and guidelines for life science products

Specialties:Analytical / bioanalytical / ADMET / PK for drug R&D programs (small & large molecules) in both sponsors and CROs environments; drugs / products commercialization

Experience

Independent Consultant / Senior Associate

Lachman Consulting Services Inc.
– Present (2 years)Westbury, NY

Sciences and Technology Division along with Regulatory Compliance in Analytical / Bioanalytical, BE/BA/PK and GxP

Performed audits (GxP Quality Systems, Study Data (BE/BA/PK, etc.) including some very high profile projects) for data integrity, CAPA, global remediation, quality and process improvement and so on.

Independent Senior QC/QA Consultant

Quality System & Compliance (QSC), Inc.
(less than a year)Greater Philadelphia Area

Perform audits (GxP Quality Systems, Study Data (BE/BA/PK, etc.), CAPA, global remediation, quality and process improvement and so on

Independent Consultant / Senior VP of Drug Development and Regulatory Compliance

Pars Pharmaceutical Consulting
(1 year)RTP, North Carolina

Lead effort on drug development and regulatory compliance (GxP) from R&D to Commercialization and assist sponsors to facilitate and expedite development and submission processes from scientific and regulatory compliance perspectives

Director of Bioanalytical PS

Forest Laboratories, Inc.
(1 year)Greater New York City Area

• Responsible for the technical, operational and strategic management of the `New Technologies, Methods Development and Validation' group in support of routine regulated bioanalysis. Support will be provided using internal resources and capabilities and external contract research organizations for the new molecular entities on the FRI portfolio.
• Serve as a senior subject matter expert with responsibility for maintaining and advancing the bioanalytical expertise and capabilities.
• Foster new ideas to the bioanalytical and drug metabolism group, network with the external scientific community, and leverage internal scientific knowledge in support of industry practices and regulations. As a member of the BDM management team, the Director will create and implement an organizational business strategy to meet the current and anticipated future business needs for the FRI programs.
• Spear head departmental, operational and process changes to maximize efficiency with appropriate scientific quality and continue to provide transparency around the departmental metrics.

Senior Director of Global R&D (special assignment)

Bioanalytical Systems, Inc.
(1 year)West Lafayette, IN

Responsible for R&D activities (methods development and validation), new technology initiatives and multisite (global) harmonization

Responsible for business and market development to realize CRO revenue to meet company goals

Senior Associate (on retained basis)

Lachman Consulting Services Inc.
(2 years)Greater Boston Area

Sciences and Technology Division along with Regulatory Compliance in Analytical / Bioanalytical, BE/BA/PK and GxP

Performed audits (GxP Quality Systems, Study Data (BE/BA/PK, etc.) including some very high profile projects) for data integrity, CAPA, global remediation, quality and process improvement and so on.

Director of Bioanalytical Chemistry / DMPK

SYNTA PHARMACEUTICALS
(3 years)

Led groups of scientists responsible for analytical/bio-analytical support in DMPK discovery (in-vitro and in-vivo) and development programs.
• Managed teams of analytical and bio-analytical capabilities to support internal R&D.
• Established and implemented automated high throughput assays for in-vitro and in-vivo ADMET projects (e.g., solubility, permeability, stability, CYP inhibitions, inductions and PK/PD/TK evaluations).
• Improved GLP quality system for on-going preclinical and clinical programs, including Phase II and III clinical trials

Managing Partner / Director

ION-E Group
(10 years)

In Charge of Strategic Planning. Promote "Integrated Online Network - Electronically" aka ION-E brand.

Director of ADMET/PK/Bioanalysis

SCYNEXIS
(3 years)RTP, North Carolina

Led groups of scientists responsible for in-vitro and in-vivo ADMET/PK/Bio-analysis for discovery, preclinical, and clinical programs. CRO Business Development.
• Developed teams of AMDET, PK, and Bio-analysis to support internal and external R&D.
• Expanded group doubled in size and increased revenue from virtually zero to $1.2M on the top of supporting internal R&D.

Director - Structure Biochemistry and Bioanalysis

CARDINAL HEALTH, INC.
(3 years)

Led a group of scientists responsible for methods development and validation for qualitative and quantitative analysis to support preclinical (in-vitro and in-vivo ADMET) and clinical studies using HPLC, GC-MS, LC-MS/MS, CE, ELISA, etc., including PK and TK data analysis and final report generation. Conducted ADMET and Bio-analysis projects for various studies.
• Developed numerous methods for drug, multi-drugs, and their metabolites in animal tissues, blood/plasma/serum, urine, and other biological matrices
• Responsible for business and market development to realize CRO revenue to meet department / company goals

Group Leader

JOHNSON & JOHNSON
(3 years)

Test Methods Development and Validation
Performed methods development and validation for qualitative (structural elucidation for unknowns in product development processes) and quantitative (trace level) analysis to support preclinical (in-vitro and in-vivo) and clinical studies.
Provided support for on-site operation, QC lab establishment, and technical transfer in terms of methods development, validation, and transfer using HPLC, GC, FT-IR, CE, LC-MS/MS, ELISA, etc. under GLP and cGMP. Actively involved in Corporate Analytical Subcommittee (CAS) within JNJ.
Developed more than 120 methods (drugs, diagnostic kits, reagents, excipients, raw materials, other biological materials) and received Six-Sigma Champion training certificate.
Met goal of completing over 100 methods according to Presidential Corrective Action Plan (PCAP) and Management Action Plan (MAP).

Principal Scientist (Team Leader)

Purdue Pharma
(2 years)

Developed and validated methods for qualitative and quantitative analysis to support preclinical (in-vitro and in-vivo) and clinical studies using GC-MS, LC-MS/MS, etc., including PK and TK data analysis and final report generation.
Established a newly equipped LC-MS/MS lab with offline automation (total 7 LC/MS/MS systems).
Developed numerous methods (drug, multi-drugs, and their metabolites in animal tissues, blood/plasma/serum, urine, and other biological matrices including humans).
Expanded group from three to 10 scientists within one year.

Principal Investigator (Study Director)

DuPont
(5 years)

Responsible for the conduct of GLP Studies

Volunteer Experience & Causes

Opportunities Michael is looking for:

  • Joining a nonprofit board
  • Skills-based volunteering (pro bono consulting)

Causes Michael cares about:

  • Economic Empowerment
  • Science and Technology

Organizations Michael supports:

Languages

  1. Japanese

  2. English

  3. Chinese

Skills

  • BIoanalysis / Analysis
  • ADMET / PK / PD
  • Six Sigma
  • Analysis
  • Bioanalysis
  • PK
  • ADMET
  • Pharmaceutical Industry
  • Lifesciences
  • Drug Discovery
  • GLP
  • Analytical Chemistry
  • ELISA
  • Drug Development
  • Cross-functional Team...
  • HPLC
  • Validation
  • Clinical Development
  • R&D
  • Chemistry
  • NMR
  • CRO
  • GCP
  • Regulatory Submissions
  • Sop
  • IND
  • Assay Development
  • Biochemistry
  • Biotechnology
  • In Vitro
  • LC-MS
  • In Vivo
  • Organic Chemistry
  • GMP
  • FDA
  • Pharmacokinetics
  • Biopharmaceuticals
  • Regulatory Affairs
  • Clinical Trials
  • Pharmaceutics
  • UV/Vis
  • DMPK
  • V&V
  • CAPA
  • Technology Transfer
  • Laboratory
  • Regulatory Requirements
  • GxP
  • Quality System
  • Formulation
  • See 35+  See less

Publications

Regulated Bioanalytical Laboratories - Technical & Regulatory Aspects from Global Perspectives(Link)

John Wiley & Sons
January 2011

NEW FROM WILEY
Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives
Michael Zhou
• ISBN 978-0-470-47659-8 • 546 pages • Cloth • January 2011•
This book provides much-needed practical information on how to generate and review data for regulatory consideration in the biotech, pharmaceutical and life science industries. It explains in detail how to develop and implement effective strategies for meeting technical challenges, Good Laboratory Practice (GLP) and GxP requirements from global perspectives, with an emphasis on tools and techniques for ensuring the quality and integrity of study data.
Readers will gain invaluable insight into the entire hardware and software qualification process as well as people qualification, learn how to get through laboratory audits and inspections with ease, and acquire a thorough understanding of all regulatory issues relevant to their work. Coverage includes:
International standards and regulations from the US FDA, USP, ICH, OECD, WHO, ISO, EMEA and EU Requirements, objectives, and implementation of GLP and GxP quality systems Facility and personnel infrastructure and qualification Techniques for modern bioanalytical / analytical sample preparation and essential concepts in extraction chemistry and separation mechanisms Specific strategies for the efficient use of laboratory automation with high throughput Instrumental analysis for hyphenated techniques such as LC-MS/MS and so on Important laboratory applications of Ligand Binding Assays (LBAs) and biomarker assays
A must-have for scientists, graduate students and quality assurance managers in bioanalytical laboratories, Regulated Bioanalytical Laboratories is also an essential reference for anyone interested in the overall technical know-how, regulatory and quality assurance trends in the field.

More publication and credentials are available upon request

More than 40 Papers Published in Peer-Review Journals

Technical and Regulatory Trainings and Presentations

Invited Speaker and Keynote Speaker at International Conferences and Proceedings

Workshop and Short Course Leader and Presenter

Education

University of Wisconsin-Madison

Special Training, PK/PD/TK/ADME

PK/PD/ADME Pharmacokinetics/Pharmacodynamics/ADME in Drug Discovery and Preclinical/Clinical Development (courses sponsored by Stephen Curry Consulting and School of Pharmacy at UWM).

Campbell University

Special Training

Joint Programs with CardinalHealth, Inc.

Activities and Societies: PK/TK/DM Data Analysis, etc. Project Management for Drug Metabolism and Pharmacokinetics Studies of New Drug Development at CardinalHealth Pharma Development

Johnson & Johnson

Corporate Accomplishment Award, Six Sigma

Activities and Societies: Six Sigma Champion Certificate

University of Delaware

Ph.D., Chemistry

Obtained my PhD degree with GPA 3.96 (full 4)

University of Hawaii at Manoa

Master of Science, Food Sciences

Additional Info

  1. Interests

    • New Technologies,
    • Innovations,
    • Giving Presentations,
    • Reading,
    • Writing,
    • Playing Ping-Pong and Golf...
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