John Iwasyk

Director, External Manufacturing & Sourcing @Otsuka Pharmaceutical Companies (U.S.)

Princeton, NJ, US

Director - External Manufacturing & Sourcing Technical and business oversight of commercial products and medical devices supplied by global contract manufacturers. Provide on-site and virtual liaison technical support (e.g. product investigations, root cause analysis, process optimization, testing) at global contract manufacturing locations. Kaizen event and FMEA evaluation of product-related events and trends. Supply chain optimization, Business Continuity Planning and cost reduction initiatives. Responsible for establishing and maintaining strategic partnerships with commercial suppliers to ensure product continuity. Developed and implemented KPI metrics program to monitor/manage supplier performance with respect to the following: • On-time delivery, cycle/lead times, yields • Right-First-Time, quality events and changes • Product defect/reject rate trending • Customer complaint trending by supplier/product • Reliability/consistency of manufacturing/packaging operations • Product Critical Quality Attribute trending Manage the transfer of new and existing commercial products to contract manufacturing sites. Lead supplier due diligence evaluations, conduct manufacturing capability/capacity assessments, prepare RFPs/RFQs, negotiate business terms and conditions and execute master service/supply agreements. Responsible for sourcing, contract negotiation/execution/management and new supplier/CMO evaluations. Conduct monthly & quarterly supplier performance reviews.

Drexel University

M.S, Engineering Management/Finance

University of Delaware

B.S, Mechanical Engineering