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Director Quality Control 1999 - 2001 <br />Responsibilities - Management of Validations and Quality Control Departments <br />- Finished product testing for lot release <br />- Equipment validations and preventative maintenance <br />- Raw material specification and testing <br />Selected Highlights - Contributed to the submission of two �i��s and one ANDA <br />- Successful FDA Pre-Approval Inspections (3). <br />CYGNUS INC., Redwood City, CA 1997 - 1999 <br />An R&D company focused on transdermal drug delivery systems and medical devices. <br />Marketed products for smoking cessation and hormone replacementtherapy. <br />Senior Manager, Laboratory �e�v�ce� <br />Responsibilities - Management of Analytical R&D and Quality Control <br />- Analytical method development and validation <br />- In-coming component specification and testing <br />- Finished Product specification and testing <br />- Component and finished product stability studies <br />� In-process testing and cleaning validation <br />- Support of process and equipment validation programs <br />Selected Highlights - Developed analytical methods for six products including the <br />Evra transdermal contraceptive system. <br />- Supported formulation development of five products <br />- CM&C sections for three NDAs and two ANT3As <br />LAREX INC., St. Paul, MN <br />- Established compliance programs for cGMPs and ��O <br />1995 - 1997 <br />A start-up company focused on extraction of specialty chemicals from North American <br />trees. Primary product is Arabinogalactan. <br />Director, Analytical Chemistry and Technical Services <br />Responsibilities - All analytical and quality control laboratory functions <br />- Chemicalprocess developmentfor extraction <br />- Primary regulatory contact for products and facilities <br />- Supervision of laboratory scientists <br />Selected Highlights - Success�t3 construction of a manufacturing facility <br />- Development and market launch of ten (10) products <br />- Efficient laboratory systems for product lot evaluation <br />