JASON Q. TAO

*** ***** **** ***** • Lawrenceville, NJ 08648 • zezq96@r.postjobfree.com • 609-***-****

SUMMARY

A methodical, practical and result-oriented pharmaceutical managing professional with all-around skills and track records in analytical sciences and pharmaceutical research & developments strives to make effective contributions and maximize team’s successes.

PROFESSIONAL EXPERIENCE

11/2009 - Present Associate Director, Analytical Sciences

11/2007 - 11/2009 Senior Manager, Analytical Sciences

International Partnership for Microbicides, Silver Spring, MD

Plan, develop and manage analytical support for pharmaceutical development from pre-clinical through clinical phases in a multidisciplinary team environment.

• Participate in discussions and determinations of corporate product development goals. Develop analytical support plans and budgets, and execute team decisions accordingly.

• Represent analytical expertise and resource for development efforts in general. Establish collaborative working relationships with other functions to ensure adequate analytical supports throughout development processes.

• Oversee, prioritize and manage multiple analytical development projects for new drug substances, pre-formulations, formulations and finished products.

• Develop, audit and secure necessary outsourcing analytical capacities. Develop work plan, negotiate contracts, and manage project executions from start to completion. Nurture effective working relationship with contract labs and research institutes in many countries and regions.

• Identify appropriate quality attributes and develop specifications for characterizations, release and stability testing of new drug substances and new drug products across different vaginal formulations including gel, ring, tablet and film.

• Coordinate development, validation and transfer of analytical methodologies to ensure the methods are suitable for their intended purposes.

• Manage release and stability testing of drug substances and finished products. Review, interpret and approve technical data and reports for its accuracy and utility.

• Author, review and approve SOPs, specifications, analytical methods, validation protocols and reports, stability protocols and reports, shelf-life assessment reports, and other technical documents as needed.

• Manage technical database through Microsoft SharePoint. Prepare technical data, reports and CMC Analytical dossier for regulatory submissions and team discussions.

• Identify potential issues, perform trouble-shooting, resolve conflicts, and provide solutions. Coordinate OOS investigations and other investigations with internal and external functions.

• Work with QA to address deviations, investigations and CAPAs and to resolve any quality issues. Improve quality system and ensure analytical practices to be appropriate for each development phase and of GMP compliance as required.

• Provide analytical expertise as needed to support other projects and activities such as proof of concept, cleaning validations, scale-up, process validations, technology transfer, Extractables & Leachables study.

05/2004 - 11/2007 Manager, Analytical & QC Labs, NexMed Inc, East Windsor, NJ

09/2002 - 05/2004 Group Leader, Analytical & QC Labs, NexMed

Led and transformed the analytical team from a simple collection of analytical chemists and equipment to a productive, flexible and know-how function.

• Oversaw analytical functions and provided value-added analytical support for NexMed’s first NDA approval and other corporate objectives.

• Built a competent team through training, understanding and appropriate uses of ICH, FDA, USP, GMP and other regulatory guidelines. Provided training in priority management, study design, bench skill, troubleshooting, problem-solving and technical writing.

• Authored analytical operational and instrumental SOPs, test methods, quality specifications, protocols and reports associated with stability testing, method validation, forced degradation, reference standard characterization.

• Exercised simple and cost-effective approach to achieve productivity, quality, flexibility and GMP compliance all together. Streamlined analytical documents to improve uniformity and compliance of analytical work. Enhanced compliance via “Test Method Modules”, “SOP Modules” and “Notebook Recording Format”.

• Oversaw stability testing program. This included preparation of protocol, assignment of analytical tasks, handling of OOS/unexpected results, management of stability database, writing of stability reports, projection of shelf-life and justification of specifications.

• Established Waters Empower Chromatographic Data System as the core analytical data system. Specialized in system setup, admin, qualification, training and troubleshooting. Customized and automated Empower via “Custom Fields, Report Templates and Data Sets” which promoted uniform report format, superior productivity and compliance by minimizing manual processes.

• Steered the characterization of novel excipient by developing and validating suitable analytical methods that utilized hyphenated techniques including LC/UV/Mass Spec/GC. Designed stability testing and forced degradation studies for identification of degradation products and pathway. Timely removal of the identified synthetic impurities resulted in significant saving in manufacturing, analytical testing and preclinical characterization.

• Provided required analytical and CMC contents for initial project explorations, INDs, NDA and partnership negotiations. Coauthored CTD Module 3 of NexMed’s first NDA filing.

• Evaluated and audited contract labs. Established contracts and coordinated outsourcing projects. Managed development, validation and transfer of analytical and bioanalytical methods. Coordinated release and stability testing of drug products at the contract labs.

• Performed and maintained qualifications of analytical instruments and stability chambers. Negotiated service contracts. Relocated and re-qualified analytical equipment in new facility in a very organized and cost effective manner.

• Promoted teamwork with other functions. Provide expertise, solutions and suggestions as needed for other challenges and issues facing the team.

12/2000 to 09/2002 Scientist II, Analytical & QC Labs, NexMed Inc, East Windsor, NJ

12/1999 to 12/2000 Associate Scientist, Analytical Group, Lavipharm

10/1998 to 12/1999 Scientist, Analytical Group, Lavipharm Laboratories, East Windsor, NJ

Developed myself into a high-performance analytical chemist with a wide range of knowledge and skills, superior productivity and leadership potential.

• Mastered method development skills and validation design through understanding of ICH/FDA guidelines. Authored methods, validation protocols and reports.

• Acquired knowledge and experience in writing quality standards and stability protocols for raw materials, intermediates and finished products.

• Authored 12 SOPs and established NexMed’s stability testing system. Utilizing skills in analytical, stability and computer software application, brought the long-overdue stability application “ScienTek Stability System” to live and full functionalities.

• Became expert in using Waters Millennium/Empower chromatographic data system and HPLC systems, and provided training to other chemists.

• Simplified the method for quantitation of alprostadil and its degradation products in cream formulations which resulted in increased sensitivity, shorten run time and improved robustness

• Accelerated formulation development by developing a one-shot HPLC/UV/Mass Spec method for simultaneous quantitation of alprostadil, novel excipient, 3 anesthetics and their degradation products.

• Provided analytical support for development of transdermal and intra-oral delivery systems, including fentanyl transdermal patch from project initiation to licensing. Represented analytical team at partnership due diligent meeting.

• Initiated and developed over 20 methods suitable for preliminary product developments. Provided other supports including FTIR, viscosity, dissolution, TLC, titration, residual solvent analysis and physical-chemical property testing as needed.

08/1997 - 09/1998 Research Assistant, School of Pharmacy, Temple University, Philadelphia

09/1996 - 07/1997 Research Assistant, School of Pharmacy, U. of Missouri at Kansas City, MO

Refreshed and consolidated knowledge base in pharmaceutical sciences, and applied research skills and analytical expertise to research projects.

• Developed and validated a GC/NPD method for quantitation of tramadol and its metabolite in plasma and brain tissue of rodents, and conduct pharmacokinetic studies. Acquired total of 38 didactic credits in various topics of pharmaceutical sciences. Received 1997-98 Ronald Gautieri Memorial Scholarship for outstanding research performance.

• Developed HPLC method for drugs used in blood-brain-barrier transportation study. Conducted metabolism study in rat liver microsome. Served as teaching assistant for undergraduate pharmacokinetics and biopharmaceutics.

08/1984 - 08/1996 Pharmacist/Scientist, Clin. Pharm. Center, Fuzhou General Hospital, China

Developed initial research ability and leadership with focuses on scientific study designs and developments of analytical methods.

• Developed and validated bioanalytical methods (LC and GC) for monitoring drugs levels in clinical. Designed and conducted ADME, pharmacokinetic and bioavailability studies.

• Guided internship research projects for 12 undergraduate students. Received six academic awards for research achievements. Served as Secretary of Fujian Division of China Pharmaceutical Society and Committee member of Fujian Chromatography Association.

EDUCATION

08/1997 - 09/1998 Master Degree in Pharmaceutical Sciences

Temple University School of Pharmacy, Philadelphia, PA

09/1996 - 07/1997 Graduate Studies in Pharmaceutical Sciences

School of Pharmacy, University of Missouri-Kansas City, MO

09/1980 - 07/1984 Bachelor Degree in Pharmacy

School of Pharmacy, Second Military Medical University, Shanghai

SPECIATIES, SKILLS AND PUBLICATIONS

Knowledge ICH/FDA/USP/EP guideline and industrial general practices pertinent to analytical supports and other aspects of drug product development

Learning Able to acquire new knowledge and assume new challenges and responsibilities in a rapid fashion

Management Over 8 years’ experience in managing analytical projects, internal and external labs, and supervising analytical professionals

Experience Team building, workflow improvement, priority management, handling of multiple projects, troubleshooting, problem-solving and risk analysis

Communication Effective communicator and negotiator in handling of disagreement and conflicts with internal functions and external organizations

Writer Proficient in authoring SOPs, specifications, methods, validation protocols and reports, stability protocols and reports, CMC documents

Specialist Waters Empower Chromatographic Data System

ScienTek Stability System

HPLC, GC, Mass Spec and other common lab equipment

In vitro release testing by Enhancer Cells

Power User Microsoft Word, Excel, PowerPoint, Project, SharePoint

Web meeting software such as MS Office Communicator/Live Meeting

Literature and knowledge search

General internet literacy

Computer and peripheral computing devices

Publications 14 publications in HPLC/GC method developments, pharmacokinetic and bioavailability studies

4 AAPS poster presentations in method development strategies and hyphenated techniques (UPLC/HPLC/GC/Mass Spec/IVRT)

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