CAREER SUMMARY

• Skilled Quality and Research Laboratory Director with extensive experience in the Pharmaceutical Industry. An excellent planner and organizer with the ability to manage a staff of scientists and chemists to reach goals while strictly adhering to budgets and cGMP, GCP and ICH / Post Approval Inspections, FDA, USP, DEA and OSHA requirements. Project Management. Train for Clinical Research of investigational sites CRF data review, study drug accountability, maintain regulatory document files and development of: project plan, reference manual, study binder, CRF guidelines, Clinical Trial: Read, write and negotiate clinical trial agreement with CRO, IVRS, EDC, Monitoring, tracking, timelines, budgets, etc. More than 15 years in management positions for Quality Control / Quality Assurance / R&D / Regulatory Affairs with multi-national pharmaceutical companies. Proven track record in project management. During the past 15 years, provided laboratory management through all governmental inspections e.g. FDA, HPB (Canadian) and international Agency: Germany, French, Hungary, Brazilian, etc. without receiving any FDA 483 citations. Self-starting, team player with strong training ability and business acumen. Fluent in Chinese, German and Japanese. Speaks French.

Confidential 2009 - present
Brewster, NY

Completed 800 hours Clinical Research Management Course at New Jersey Institute of Allied Health LLC, Elizabeth, NJ. January 2011 to October 2011.

Quality Control/ Quality Assurance Sr. Consultant

• Completed working as Quality Control/ Quality Assurance Consultant for Sandoz Pharma in Salzburg, Austria. Responsibilities include assessment of existing laboratory quality systems to ensure compliance in preparation for FDA audit.
• As Quality Assurance/ Quality Control Consultant for a start-up soft gel capsule and tablets manufacturer of Rx products and OTC pharmaceuticals in New Jersey, responsibilities included overall planning and management of QC laboratory. Specifically; coordinated cGMP for local and international manufacturing facilities, performed audits for API and third-part manufacturing, prepared SOPs, trained chemists in laboratory techniques, and performed and documented laboratory investigations.

As Quality Assurance Consultant to a New York State biotechnical research company, responsibilities included planning and initial oversight of QA department. Specifically, coordinated cGMP facility audits, conducted clinical and non-clinical CROs, data management and analytical sites audits, contract manufacturing and vendor facility inspections. Assessed approval of deviations and out-of-specifications data (OOS) as well as reports. Performed liaison and coordination with FDA and other government agencies’ inspections to ensure compliance for FDA inspection audits. Staff training. Provided input regarding current regulatory guidelines and regulatory support. Coordinated with

• Regulatory consultants in preparation of INDs, Protocol Amendments, IND Annual Reports, etc.

Confidential 2007 - 2009
Confidential NY, USA
Manager, Laboratory Operations

Responsibilities:
Directed the operation of the Day Shift Assay Groups for Laboratory Operations Department. Responsible for Quality Control Testing: Analytical Chemistry, Stability, GMP products testing. Managed the day-to-day activities of scientists/analytical chemists. Provided expert advice to resolve analytical and technical problems. Ensured compliance to regulations, trained personnel in the use of pharmaceutical technological methods using analytical instrumentation. Reviewed new methods Technology Transfer to QC Laboratories from other Watson sites.

Confidential 2004 - 2007 
Madison, AL, USA
Quality Control/ Quality Assurance Consultant

• Assisted several start-up companies in providing Quality Assurance and Quality Control services, e.g. SOP preparation, Analytical Methods, and auditing of Third-Party manufacture and testing laboratories, etc. Companies included manufacturers & distributors of liquid formulation and OTC dietary supplements.
• Responsible for planning and, organizing the Quality Department in preparation for FDA inspection audit, Provided assessment of quality systems to ensure compliance with government/vendor guidelines. Implementing safety training. Provide on-call technical support to the quality and production departments.

Confidential 2002 - 2004
(Shearwater Corporation),
Huntsville, AL, USA

Providing PEGylation technology to customers including Amgen, Roche, Pfizer, Johnson & Johnson, Celltech, DuPont, Regeneron, Serono, Maxygen and United Therapeutics.

• Director - Quality Control

Responsibilities:
Directed the operations of the Quality Control Laboratory. Responsible for Quality Control Testing, including Analytical Chemistry, Stability, GMP products, and Research products testing. Managed the day-to-day operations of a laboratory with research scientists/analytical chemists. Provided expert advice and resolution of analytical and technical problems. Ensured regulatory compliance, developed standard operating procedures and trained personnel in the use of pharmaceutical technological methods using analytical instrumentation. Implemented technology transfer from Analytical R&D to QC Laboratories. Developed and implemented of Quality System that assured compliance with all international regulatory requirements. Provided oversight of Quality Control activities such as implementation of efficiency and re-engineering programs to improve overall laboratory operation. Developed departmental budgets, financial plans and forecasts. Organized resources (equipment, finance & personnel) to meet assigned project targets.

Achievements:

• Initiated laboratory performance program to ensure current FDA Good Manufacturing Practices compliance.
• Developed and implemented a software-based Stability Study Program resulting in improved overall accuracy and efficiency of the stability program.

Confidential MA Jan. 2002 – Sep. 2002

A FDA-licensed facility for the development & manufacture of human vaccines, plasma and monoclonal antibodies. For over 100 years, MBL has been charged with improving public health through applied research, development and production of biologic products. MBL specializes in the development and manufacture of “orphan biologicals” , that is life-saving product for use in limited or special populations. Recent examples include the immune globulins effective against Cytomegalovirus in organ transplant recipients, Respiratory Syncytial Virus in high-risk infants and Varicella-Zoster Virus in children with leukaemia.

Director - Quality Control
Responsible for planning, directing, managing and organizing the Quality Control Lab comprised of QC Product Testing, (QC Chemistry, QC Stability and QC Animal Resource and Testing), QC Operations Support (QC Materials Control, QC Microbiology/Environment Monitor) and Plasma Program/Screen Lab), QC Assay Validation and Virology and QC Validation Group 2, respectively. Provided expert advice to solve analytical difficulties and technical problems. Organizing resources (equipment, finance & analysts) efficiently to accomplish assigned projects. Ensured compliance with GMP/GLP. Implemented S.O.P. and lab safety training, on a regular basis. Provided support for Method Development & Validation, Formulation and Regulatory Affairs.

Confidential 1992 - 2001 // Toronto, Ontario, Canada 
Under Merck Generics Group, an international pharmaceutical firm comprised of Generics UK Ltd., Resolution (Quality Pharmaceutical Actives, UK), Alphapharm PTY Ltd. (Australia), Pacific Pharmaceuticals Ltd. (New Zealand) and Genpharm (Canada). Genpharm Inc. manufactures over 85% Solid Dose Pharmaceuticals. The 45% of products distribute to the USA and 20% sale to 16 European countries.

Responsibilities:
Responsible for development and implementation of policies, procedures and documentation to ensure the product quality compliance to cGMP and GLP. Direct Quality Analytical Services Department and the Research & Development Department. Providing expert advice to solve analytical difficulties and technical problems. Budget departmental annual expenses efficiently to accomplish assigned projects. Interact with FDA (US), HPB (Canada) and European (German, French, etc) regulatory agencies. Implementation of regularly-scheduled S.O.P. and lab safety training. Support for Method Development & Validation, Formulation and Regulatory Affairs. Implementing & directing the functions of GLP Quality Assurance Unit. Maintaining a master schedule of all laboratory studies, maintaining all the protocols for validation and specific studies, inspecting the laboratory operation on a periodic basis, identifying and trouble shooting to resolve problems.

• Started-up the R&D, QC Labs. R&D Stability and Market Stability Labs.
• Planned, directed, managed & organized resources (equipment, finance & manpower) efficiently to meet assigned projects and to ensure cGMP/GLP compliance.
• Established and directed growth of R&D lab from staff of 8 to 32 chemists/analysts in one year. Purchased lab equipment of $ 1.1 million and reduced expenditures for outside lab testing from $ 500,000 annually to virtually nil.
• Responsible for the quality of all data generated in the lab.
• Provided expert advice to solve analytical difficulties and technical problems in detail for all lab affairs.
• Organized and implemented the lab safety training program on a regular basis.
• Conducted and scheduled testing in response to submitted ANDAs & NDS, NONC.
• Saved $330,000 by negotiating advantageous purchase prices for laboratory equipment (HPLC, GC with Headspace, Dissolution systems, DSC, FT-IR Spectrometer, Polarimeter system, etc.)
• Recruited, selected, motivated & trained staff for Research and Development/Quality Control analytical laboratory operations.
• Point of liaison on analytical matters for other Merck Generics companies, joint venture companies & contract analytical labs.
• Developed and validated analytical methods (eg., GC, HPLC, UV, TLC, etc.).

Confidential 1991 - 1992
Toronto, Ontario, Canada
A 100% Canadian-owned, independent firm which produces specialty chemicals for research laboratories, fine chemicals for the pharmaceutical formulation industry and also develops new and innovative technologies for the production of fine chemicals.

• Director Quality Control & Regulatory Affairs

Responsibilities:
Managing the daily operations of the Quality Control Laboratories and Regulatory Affairs.

• Started-up the R&D and the QC labs at Pharmaglobe Manufacturing Ltd. (Windsor, Nova Scotia). Recruited and trained new lab chemists/analysts.
• Increased productivity by more than 20% by modifying analytical methods and ensuring lab staff training.
• Prepared four new drug submissions to FDA, HPB and New Zealand; also submitted a General Plant Master File to the FDA and the HPB.
• Sourced, negotiated purchase price and quality of APIs from Italy (FIS Fabbrica Italian Sintetic S.p.A., Sifavitor S.p.A., etc.), Switzerland (Cilag AG, ALCO Chemical for Betametasone, etc.), Spain (Uquifa Barisinte for Ranitidine HCl)

Confidential 1990 - 1991
Pharmaceutical Division 
Montreal, Quebec, Canada 

Currency, NOVARTIS.A multi-national company comprised of pharmaceutical, agriculture, animal care, and vision care products, etc The pharmaceutical division manufactures prescription as well as OTC (over-the-counter) drugs

• Analytical Manager, Quality Assurance Department

Responsibilities:
Managing the Analytical Section comprised of the quality control group (raw materials, in-process & finished product), the stability and analytical method development groups, and responsible for method reviewing and ensuring GMP/GLP compliance.

Achievements:

• Managed a budget of approximately $1.2 million annually for the Analytical Section, planned areas of saving and outlined a program which provided incentives to employees to create new ideas for increasing savings.
• Increased productivity by over 15% as well as the accuracy of tests by intensifying automation (purchased additional auto-samplers for GC and HPLC).
• Implemented a system of retaining samples until a consignment was received for improved evaluation of raw materials from suppliers.
• Introduced an improved system for outside laboratory testing which resulted in cost savings, accelerated payments and reduced complaints.
• Introduced a Master Log Book and a Centralized Filing System for easy access to data, facilitating data retrieval and saving considerable time.

Confidential. 1986 - 1990
Montreal, Quebec, Canada
A bulk pharmaceutical and fine chemicals company which manufactures active pharmaceutical products by chemical synthesis. Sales primarily to the U.S., Canada and European countries. Production on a 24-hour, 3-shift basis.

• Manager, Quality Assurance

Responsibilities:
Managed & supervised the QA Department including Quality Control and Analytical Chemistry Groups.
Assured the testing and quality of raw materials, in-process testing, and intermediate and finished product testing for chemical syntheses in compliance with GMP/GLP. Developed instrumentation methods (HPLC, GC, FT-IR, UV) and wet chemistry analytical methods. Prepared new drug submissions to FDA, HPB, the U.K., France, Germany, the Netherlands and Ireland.

Achievements:

• Liaison with outside suppliers for service and equipment, inspectors and other pharmaceutical firms.
• Implemented a 2nd shift within the QC Group and introduced a Foreman Training Program for additional tests during night shift including: pH testing, GC injection and an LOD test, thereby increasing productivity by 30 to 40%.
• Initiated a company-wide self-inspection program & implemented a simulation recall procedure.
• Coordinated 11 new drug submissions approved by FDA, HPB, the U.K., France, Germany, the Netherlands and Ireland.
• Sourced, negotiated purchase price and quality of APIs from Italy (Hovione Sociedade Quimicq, S.p.A.; SIMS, Societa Italiana Medicinali Scandice; Erregierre S.p.A. for Ticlopidine HCl, etc.), Spain (Uquifa Barisinte for Ranitidine HCl; Farmhi Spania, S.A. Fine Chemicals, etc), UK (Generics LTD.), France (Prographarm Laboratories, etc) and India (Shasun Chemicals And Drug Ltd.).

Confidential. 1984 - 1986
Montreal, Quebec, Canada 
ICN (International Chemical Nuclear) Canada, a U.S.-based (California) pharmaceutical company which
manufactures tablets, capsules, syrups, suppositories, enemas, gels, creams, lotions and shampoos.

• Assistant Manager, Quality Control Department

Responsibilities:
Supervise the QC staff of chemists and technicians, develop analytical methodology, monitor the stability program and ensure GMP/GLP compliance.

Achievements:

• Executed batch calculation of tablets, capsules, syrups, suppositories, enemas, gels, creams, lotions and prescription shampoos.
• Provided information about company products to clients, (i.e. hospital physicians, nurses and pharmacists).

Confidential 1974 - 1984
Montreal, Quebec, Canada 
Current Wyeth, under the American Home Products umbrella, a pharmaceutical company heavily involved in new drug research During this period there were 850 employees, including 385 employees in 12 research departments.

• Senior Research Assistant, 1981 - 1984
• Research Assistant, 1974 - 1981

Responsibilities:
Responsible for research, in the drug metabolism section, primarily on the synthesis and radio-chemical purification of 14C-labelled compounds selected for Ayerst\'s new drug development program.
Achievements:

• Determined the radiochemical purities by T.L.C. autoradiograph in three solvent systems to obtain purity greater than 99%. Applied UV, IR, NMR, MS and HPLC analyses for structure elucidation.
• Studied the metabolism of new drugs by quantitative analysis of radioactivity in rats and dog serum, bile, tissues and urine after oral administration of C-14 labelled compounds.
• Synthesized 8 14C-labelled compounds selected for Ayerst\'s new drug development program.

Ph.D. Research Study, Chemistry Department, (uncompleted due to personal reasons) 
M.Sc. in Chemistry 
Graduate Study 
B.Sc.

LANGUAGES

Fluent in English, Chinese, German and Japanese. Spoken French.

PROFESSIONAL AFFILIATION

Member, Association of the Chemical Profession of Ontario (Chartered Chemist)
Member, The Chemical Institute of Canada
Member, Ordre Des Chimistes Du Quebec
Member, Pharmaceutical Sciences Group
Member, Society of Quality Assurance (USA)
Member, Drug Information Association (USA)