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Director Quality Control <br />Responsibilities <br />Selected �i�hYi,�l�ts <br />1 �9`3 - 2001 <br />- Management of Validations aud Quality Control I��.part�.e�1t� <br />- �inisf��d producttest.ing for lot release <br />- Equipment validations � � n•� preventative maintenance <br />- Raw ��terial specification and testing <br />- Coz3ti-ib�ted to the submission of �ro NDAs and one f'�]I)A <br />- Successful FDA Pre-Approval Inspections (3). <br />CYGNUS �NC., Redwood City, CA 1997 - 1999 <br />A� R��C] c�i�pa�ay focused on �ansd�nraal ci�-u�; delivery systems and medical devices <br />Marketed products for s�x��k��g cessation ��: �tl ha�-ano�i� replacement therapy. <br />Senior Manager, Laboratory Services <br />Responsibilities d Management of Analytical R&.L� and Quality Control <br />Selected Highlighis <br />LARE� INC., St. Paul, MN <br />- ��iytrcal g�et�ad development aaie� validation <br />� In-coming coznpoi�ez�t specification and testing <br />- Finished ��x������L specification a�� testing <br />- Component and finished product stability studies <br />� In-process testing and cleaning validation <br />- Support of process and equipment validation programs <br />- Developed analytical zne�sods for six products ir�clud��g the <br />Evsa transdennal contraceptive system. <br />- Supported formulation de�elopmeni: of five products <br />- CM&C sectia��s for three NDA,s and two AI�TDAs <br />- Established compliance prog���aius for cG1VrPs and ISD <br />1995 - 1997 <br />A start-up company focused on extraction of specialty chemicals from N�rY�� American <br />trees. Primary product is Arabuaogaldctan_ <br />Director, Analytical Chemistry and Technical Services <br />Responsibilities -�ll analytical and quality control laboratory functions <br />- ChenucaX process development for extraction <br />- Primary regulatory contact for produc�� and facilities <br />- Supervision of labo�a�oiy scientists <br />SelectedHigl�ligl�ts � Successful construction of a ma�au��ct�i�Ig facility <br />-- Developz-�ed2t and �nE�r�Cet la�c13 of te�. (I 0) products <br />- Efficient laboratory systems for product lot evaluation <br />