Responsibilities include: *Leads the transfer of production to contract manufacturing houses (both U.S. based and outside the U.S.) *Collaborates with and leads others on technical issues in manufacturability and transfer of manufacturing *Key technical contributor (with a quality mindset) in a complex environment of equipment development *Ability to solve complex technical challenges and design optimization *Mentors colleagues and shares expertise

Auvi-Q / Allerject Commercialization and Industrialization Project Manager. Includes managing a $16M budget, scope and schedule of multiple suppliers (world-wide), contractors, temporary workers and internal staff.*Managed the automation & qualification for the automated manufacturing lines at Medivative and multiple supplier locations*Managing production efficiency and yields for profitability*Lead company in Validation and GAMP training*Supported comparability studies in effort to prove manufacturing process equivalency *Managed the design/build/commissioning & qualification of the manufacturing facilities for the Auvi-Q/Allerject product and other Medical Devices (Cleanroom, Warehouse, Refrigeration)*Managed Cold-Chain supply logisticsPreviously: Technical Project Manager for the Auvi-Q & Allerject Epinephrine Auto-Injector Combination Product (www.Auvi-Q.com) Industrialization & Commercialization *Managed Cold-Chain supply logistics*Thorough understanding of cGMP's and QSR's*Practical understanding of Medical Device Development including: design controls, Risk Management, Verification & Validation, ISO Standards, FDA/Regulatory affairs

Outside Sales & Project Managment

Project lead for validation - VMP, CSV, IQ, OQ, PQ