Oversaw all Operations management which included production planning, procurement, supply chain coordination, warehouse management, manufacturing engineering, recruiting, employee development and mentoring.

Mixed Martial Arts Studio for kids and adults

Directed Manufacturing Engineering resources to provide technical support for all device production and service lines minimizing interruptions in supplying product to ongoing clinical trials, oversaw manufacturing transfer of all new products developed by R&D to ensure meeting schedules and budget expectations. In addition to device production support was also responsible for project planning, continuous improvement, validation support, fixture design & test, NCMR/Complaint investigations, program management and product development.

Built strong team collaboration with Design Engineering, Clinical, Regulatory and Quality groups through prompt direct support and customer service proficiency to increase ability to get products to clinicians faster. Provided Operations leadership and guidance during audits with Roche and Medimmune, TUV and FDB.• Reorganized RGA process and assigned point person, reducing open RGAs & open time from months to days.Managed collaboration with Operations to set up floor stock system reducing inventory pulls, kitting time and increasing impacted warehouse space for more critical parts.Played key role in company move to Wateridge facility, including creating and approving internal design, transfer and validation plans for all controlled spaces.Implemented new System Change process to capture changes to controlled GMP facility, utilities, equipment systems.

Led development of supply chain, purchasing groups and facilities operations after the VGX/Inovio Biomedical merger. Led Distribution to meet all Clinical trial demands with no missed shipments even through subsequent years.

Provided engineering product support for MedPulser and Elgen Product Lines.

Project Lead for Pouch Machine Project multidisciplinary team of 10 introducing new packaging process method.Provided leadership to project teams bringing new commercial products to company’s Solution portfolio.Formulated cost analyses and produced process flow charts to create lower product standard costs while producing cost-effective production solutions for new and existing product lines.

Performed design and implementation of manufacturing processes, instrumentation and equipment from development through pilot and into manufacturing. Involved in new product scale-up, process optimization, technology transfer and process validation testing.

Oversaw product quality of diagnostic disposables during production. Devised and executed engineering studies to address and optimize productivity.

Performed process/validation engineering on ultra-filtration systems, bio-process vessel systems, GMP regulated batch records and SOPs, clean room procedures, aseptic technique, and good documentation practices to maintain four product lines.