Timothy E. Woenker

Timothy Woenker is a founding partner of Novilytic and has operational responsibility for, design implementation and manufacturing activities associated with the Noviplex product line.

As Director of Operations, and later as President of Chematics, Incorporated., Mr. Woenker has over 30 years of broad experience in the design and manufacture, registration, and approval of a variety of disposable Class I and II in-vitro diagnostic medical devices. Experience includes manufacturing process development and process validation activities to support the manufacture of multiple disposable IVD devices, technical oversight, process development and process validation for 6 different IVDs, development and implementation of Quality Assurance Programs for compliance with FDA, cGMP, IVD manufacturing regulations under 21CFR Part 820 regulations for 6 individual IVD products, directed clinical trials to support data generation, compilation and reporting of results from performance studies for FDA 510(k) clearance of four separate in-vitro diagnostic devices, directed ISO-13485 Registration and CE marking of multiple IVD Products and responsible for the purchase, installation, development and operation of a 40L bioreactor process facility for the production and purification of a specific enzyme from yeast.