Michael Zhou Email & Phone Number

Cary, Nc, Us

Hamden, Connecticut, Us

Lead effort on drug / medical device 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; QC/QA for APIs, and DPs in various dosage forms, regulatory filing (IND, NDA, ANDA, BLA, etc.), QMS and Quality Inspection Module improvement, GAP and CAPA assessment, operational enhancements and remediation

Westbury, Ny, Us

Sciences and Technology Division along with Regulatory Compliance in Analytical / Bioanalytical/Microbiological Methods, QC/QA, BE/BA/PK, GxP Quality System Baseline Audits, Assessments and Remediation. Performed consulting projects within the areas of science and compliance (GxP) for life science industries (IND, NDA, ANDA data review, etc.). Method validation and transfer (R&D to QC Labs). Analytical runs data, data integrity assessment, and manufacturing batch records review plus BE/BA studies; data and quality system assessment, PQA, GAP analysis, CAPA evaluation and remediation; Laboratory OOS, OOT and Root Cause Investigation (RCI) and analysis; purity / potency / impurity / stability analysis; Laboratory staff technical and regulatory training; Change Control for Quality Management in support of APIs and different dosage forms like solid, inhaled, injectable, etc.) and quality system audits including PAIs and Mock audits. QC/QA for APIs, and DPs in various dosage forms, regulatory filing (IND, NDA, ANDA, BLA, etc.) QMS and Quality Inspection Module improvement, GAP and CAPA assessment, operational enhancements and remediation

Westbury, Ny, Us

Sciences and Technology Division along with Regulatory Compliance in Analytical / Bioanalytical / Microbiological Methods, QC/QA, BE/BA/PK and GxP assessment and remediationPerformed audits (GxP Quality Systems, Study Data including some very high profile projects for data integrity, GAP / CAPA, PQA, global remediation, quality and process improvement and so on.Performed and led consulting projects within the areas of science and compliance (GxP) for life science industries (IND, NDA, ANDA data review, etc.). Method validation and transfer (R&D to QC Labs). Analytical runs data and manufacturing batch records review plus BE/BA studies; data and quality system assessment, gap analysis, CAPA evaluation and remediation; Laboratory OOS, OOT and Root Cause Investigation (RCI) and analysis; purity / potency / impurity / stability analysis; Laboratory staff technical and regulatory training; Change Control for Quality Management in support of APIs and different dosage forms like solid, inhaled, injectable, etc.) and quality system audits including PAIs and Mock audits.

Quantic has provided expertise in such areas as: business, operational, marketing and manufacturing strategies; organizational structures; management controls; clinical trial practices; product research and development; manufacturing and quality systems methodologies and practices; compliance programs; bioequivalency studies; data integrity and accuracy reviews; FDA, EMA and other regulatory matters; and FDA consent decree management and certification activities; Global remediation executionAnalytical runs data and manufacturing batch records review; Laboratory OOS, OOT root cause investigation (RCI), GAP and PQA / CAPA assessment, data integrity assessment, investigation, root cause analysis and remediation; GxP quality system assessment and QC lab personnel training, gap analysis, Master Remediation Plan (execution and verification); Manufacturing Shop Floor Monitoring, etc.http://www.quantic.com

Perform audits (GxP Quality Systems, Study Data (BE/BA/PK, etc.), QC/QA Analytical / Bioanalytical, Microbiological Methods, Data integrity assessment, GAP, CAPA eva;uation and implementation, global remediation, quality and process improvement and so on

• Responsible for the technical, operational and strategic management of the `New Technologies, Methods Development and Validation' group in support of routine regulated analysis. Support was 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 analytical expertise and capabilities.• Foster new ideas to analytical 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 created and implemented 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.• QC/QA, regulatory filing (IND, NDA, ANDA, BLA, etc.), QMS and Quality Inspection Module improvement, and operational enhancements and remediation if applicable• Project management for all of phases and processes (R&D and commercialization). Performed GxP quality system (GAP and CAPA assessment) and data review / audits for NDA and ANDA submissions (e.g., PAIs preparation, etc.).

West Lafayette, In, Us

Responsible for R&D activities (methods development and validation), new technology initiatives and multisite (global) harmonization per GxP regulationsResponsible for business and market development to realize CRO revenue to meet company goals

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

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.Led groups of scientists responsible for analytical support in DMPK discovery (in-vitro and in-vivo ADMET) and clinical development and commercialization programs (CMC and cGMP); • Performed method development, validation, transfer and sample analysis of APIs/DSs/DPs plus quality and change management system; Laboratory management and staff training; Project management for all of phases and processes.• Improved GXP quality system for on-going preclinical and clinical programs, including Phase II and III clinical trials and CMC regulatory compliance• QC/QA, regulatory filing (IND, NDA, ANDA, BLA, etc.), QMS and Quality Inspection Module improvement, GAP and CAPA assessment, operational enhancements and remediation

Jersey City, New Jersey, Us

Led groups of scientists responsible for in-vitro and in-vivo ADMET/PK/Bio-analysis for discovery, preclinical, and clinical programs. CRO Business Development. Performed method development, validation and transfer for all phases of studies and processes plus quality management system; Analytical support for APIs synthesis and scale up (process chemistry); Laboratory management and staff training• Developed teams of AMDET, PK, and Bio-analysis to support internal and external R&D.• QC/QA, regulatory filing (IND, NDA, ANDA, BLA, etc.), QMS and Quality Inspection Module improvement, GAP and CAPA assessment, operational enhancements and remediation• Expanded group doubled in size and increased revenue from virtually zero to $1.2M on the top of supporting internal R&D.

Dublin, Oh, Us

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. Performed method development, validation and sample analysis for various studies and processes (APIs, DSs, DPs and related substances).• Developed numerous methods for drug, multi-drugs, and their metabolites in animal tissues, blood/plasma/serum, urine, and other biological matrices. Performed analytical methods for potency, impurities and stability indicating studies• QC/QA, regulatory filing (IND, NDA, ANDA, BLA, etc.), QMS and Quality Inspection Module improvement, GAP and CAPA assessment, operational enhancements and remediation• Responsible for business and market development to realize CRO revenue to meet department / company goals

New Brunswick, Nj, Us

Test Methods Development and ValidationPerformed 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).Provided support in Change Control for Quality Management in support of product life cycle management and quality improvement and regulatory submission (CMC sections preparation, etc.); project management for all of phases and processes and processes (R&D and commercialization).

Stamford, Ct, Us

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.Coached and managed an analytical team to develop and validate methods for qualitative and quantitative analysis to support preclinical (in-vitro and in-vivo) and clinical studies using UPLC, FT-IR, GC-MS, LC-MS/MS, ELISA/LBAs, Immunogenicity assays, etc., including PK and TK data analysis and final report generation. Change Control for Quality Management in support of product life cycle management and quality improvement and regulatory submission (CMC preparation).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.

Wilmington, De, Us

Responsible for the conduct of GLP Studies

Shanghai Pharmaceutical PlantQuality Control Laboratories - Analytical, Bioassays, Microbiological Testing (MD/MV/MT/SA).

Special Training, Pk/Pd/Tk/Adme

Special Training, Part Of Mba

Corporate Accomplishment Award, Six Sigma

Ph.D., Chemistry

Master Of Science, Food Sciences

Bachelor Of Science, Analytical Chemistry