- Drug stability: Pharmaceutical analysis and validation and transfer.
- Technical knowledge across multiple disciplines of drug development.
- In depth knowledge of drug stability, cGMP/GLP and method development and validation.
- Experience with current FDA regulations and compliance, ICH, and global requirements, cGMP/GLps, CMC, IND, NDA, sNDA and annual reporting.
- Experienced addressing commitments related to FDA Consent Decrees.
- National and international oral presentations on "Stability" and "Lab Best Practices."
- Managed the stability program for new development or marketed products, coordination of non-stability samples.
- Established change control procedures to transfer stability samples from different U.S. and international sites.
- Designed standard stability protocols, reviewed stability data, performed statistical evaluation, prepared stability sections of Chemical Manufacturing and Controls (CMC) registration dossiers, managed stability studies, oversaw the validation and maintenance of stability chambers.
- Administrated the Research and Development Stability Review Board and Pharmaceutical Marketed Product Stability Review Board.
- Developed standard stability protocols for research and development stability studies and marketed products.
- Served as the stability expert for research and development and represented stability issues project teams.
- Managed the Stability Testing Laboratory responsible for stability samples and raw materials, including scheduled analytical testing to meet USP/EP/JP or in-house specifications.
- Designed and set up stability studies according to ICH guidelines and regulations and managed day-to-day operation of analytical labs.
- Developed, implemented and managed system for recording and tracking of testing in research and development.
- Maintained the stability data base of R&D and manufacturing sites, database of research and development, the manufacturing sites and archived key information according to SOPs.
- Prepared internal reports and CMC analytical submissions for INDs, NDA, new submissions, supplements, special regulatory request and worldwide registration dossiers. Involved in FDA response to stability related regulatory issues.
- Conducted technical evaluation and selection of CROs.
- Facilitated method development and method validation at CROs labs; managed method transfer to the manufacturing sites; generated new database to set new specifications; and supported post approval submissions.
- Managed all outsourcing activities of analytical testing, tracking and monitoring progress.
- Participating in site audit programs of manufacturing and CROs.
Life Cycle Product Evaluation
- Evaluated method validation procedures through life cycle of the products.
- Managed Wyeth Vaccines marketed product stability program by overseeing the design, implementation and execution of stability protocols.
- Supervised development, validation and optimization of analytical methods including cleaning methods.
- Automated methods to improve efficiency and assured that group performs in compliance with current regulations.
- Automated dissolution methodology using Zymark robot used in the Tablet Processing Workstation.
- Lead multidisciplinary teams to address Consent Decree commitments of manufacturing site.
- Developed scope, plan, time lines and resources to ensure compliance to cGMPs regulations, ICH guidelines and quality practices.
- Provide training related to stability program or cGMP topics to pharmaceutical industry.
- Developed training procedures according to SOPs, cGMPs and ICH regulations.
- Conducted training courses of Advance HPLC, Stability Testing, Method Transfer for several national organizations such as ACS, AAPS, EAS and the Pharmaceutical Training Institute.
- Conducted workshops and participated as invited speakers at national and international conferences.
Undisclosed Consulting Company, Analytical Development and Stability, 2004 - Present
- Technical Director and CEO
Undisclosed Research Institute, 2003 - Present
- Consultant, Analytical Development, SPRI
United States Pharmacopeia, 2010 - 2012
- Director, Pharmacopeia Education
Undisclosed University, 2010 - Present
- Adjunct Faculty, School of Pharmacy, QA/RA Program
Undisclosed Institute of Technology, 2010 - Present
- Adjunct Faculty, Regulatory Certification Program
Wyeth Vaccines, 2002 - 2003
- Manager of Marketed Product Support Stability, QA Compliance and Auditing
Bristol Myers Squibb, 2002 - 2003
- Manager, Research and Development Analytical Testing Lab, Excipient and Outsourcing
Dupont Pharmaceuticals Co. , 1991 - 2002
- Manager, Research and Development High Throughput Stability Testing Lab and Outsourcing
ICI Americas, Inc., (Astra Zeneca), 1987 - 1991
- Sr. Analytical Chemist, Analytical Development and Automation
Honors & Publications
Academic and Professional Affiliations
- United States Pharmacopeia (USP - Chair
- American Association of Pharmaceutical Sciences (AAPS) - Chair of Distance Learning Committee, Chair and Founder of Stability Focus Group
- APQ Webmaster, APQ & RS abstract screening committee sub-chair. APQ Program Committee.
- Eastern Analytical Symposium (EAS) - Governing Board member, Chair, Short Course Committee.
- Housing Committee, Employment Program, Workshop Committee, Publicity Committee.
- Consumer Healthcare Product Association (CHPA)
- Pharmaceutical Outsourcing Management Association (POMA) - Member.
- Pharmaceutical Stability Discussion Group.
- Pharmaceutical Excipient Discussion Group.
- American Chemical Society (ACS) - Chairperson of Continuing Education and Membership Committees.
- DuPont Pharmaceutical Asian Americans - Leadership Team, Fund-raising, Program and Publicity.
- Edited 2 books and 16 other publications.
- Conduct professional training courses for over 15 cGMPs topics.
- Invited speaker at 26 national and international conferences.
- M.S., Analytical Chemistry, Villanova University, Villanova, PA
- B.A., Chemistry/Mathematics, Millersville University, Millersville, PA