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2006_0612_Packet
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2006_0612_Packet
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Director Quality Control <br />Responsibilities <br />Selected �ig1�i��ts <br />�ii � � <br />-- Management of Validations and Q�a�ty Control Departments <br />- Finished product testing for lot release <br />- Equipment validations and preventative maintenance <br />- Raw material specification and testing <br />- Contributedto the su�z��iss:an oftwo �T�As t�ii�i one ���'::x�i• <br />- Successful F �;� Pre-��pz-ovzl �nspec�icr�s (3). <br />CYGNUS TNC., Redwood City, CA 1997 - 1999 <br />�rt �#.&� company focused on transdermal drug delivery systems and medical devices. <br />Iv,��ri�°twd products for ��.c�r��� cessation and norr=on� replacement therapy. <br />Senior Manager, Laboratory Services <br />Responsibilities - Management of Analytical �c�a� and Quality Control <br />- Analytical method development and validation <br />�- in-coming component specification and testing <br />- Finished Product specification and testing <br />- Component �n,� �nisne�. 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 inciuding the <br />�vra transderrYal contraceptive system. <br />- Supported formulation development of five products <br />- CI"v�&C sections for three �'3��� and two ANi3� <br />LAREX T�NC., St. Paul, NII� <br />- Esta�biish�d compliance �rogra�ns for ���'s and :,�',� <br />1995 - 1997 <br />A start-up company focused on extraction of specialty chemicals from t�Tarth American trees. <br />Primary product is Arabinogalactan. <br />Director, Analytical Chemistry and Technical Se�vices <br />Responsibilities -;�I[ analytical and quality control laboratory �a�c�icr�s <br />- Chemical process development for extraction <br />- Pru°nary regulatory contact for products and facilities <br />- Supervision of laboratory scientists <br />SeiectedF����t� - Sacces�fui construction of a manufacturingfaciii�� <br />- Development and market launch of ten (10) products <br />� Efficient laboratory systems for product lot evaluation <br />� <br />
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