Ryan K.

Device Development & Clinical Packaging Engineering -

Lead R&D Packaging Engineer for NPI and on-market support

Lead packaging engineer for Humira, new product introductions and on-market support. Auto-injector and prefilled syringe for US and ROW.

• Lead packaging portion of strategic R&D initiative to develop and implement creative and market differentiating products in the following market segments (Consumer Goods, Cosmetic, Personal Care, Hard surface disinfectants, OTC) • Focused largely on laminated films, peel & reseal labels, injection and blow molded bottles, trigger sprayers,liquid fill, finger pumps, tubes, and canisters. • Analyze and resolve packaging related CAPA or manufacturing constraints for primary, secondary, and tertiary packaging. • Managed customer creative artwork (die-lines, file-exchange, proofs (PDF/contract), rolling changes) for film/labels, cartons & shippers. • Launched Fortune 500 company new market segment; entry into OTC/Medical Device. Developed packaging specification and stability program.

Collaborated with BD team to meet customers needs by quickly turning around RFQ's and scope change requests in order to meet production schedules. Effective in writing quotes for pharmaceutical tablets and capsules (fluid bed drying and granulation, blending, compression and encapsulation) In charge of forecasting 20MM in yearly revenue in a very fluid business dynamic.

Process Engineer: a member of the Manufacturing Science & Technology team. Uses statistical thinking and methods to understand process variability and capability and drive improvements. Determines process capabilities and bottlenecks, implement improvements, and develop contingency plans for capacity/productivity increases. Provide technical investigations for complaints. Identifies failure modes of equipment and maintenance strategies to mitigate impact of failure. Stay current on existing technology by meeting with vendors and manufacturers in order to evaluate new equipment and procedures, which may help improve production currently or in the future. Monitor and build strong safety culture Identify hazards and support countermeasure implementation.

The program is a two-year leadership opportunity consisting of three separate job assignments lasting eight months each. The assignments are responsible for a variety of responsibilities such as coordination of daily activities, technical/process improvement and general departmental support. The program provides critical on-the-job experiences in operation and broader business areas. Global Procurement • Lead the in-sourcing of site’s printed components to inter company supply; yearly revenue value of items transferred $2MM • Co-lead a strategic packaging materials consolidation project (all business segments); value > $8MM • Work with supply base and sites to make recommendations of next generation of films, foils, liners and resins; conducted bid on Catalent’s corrugated business of $4MM annual spend. Printed Components • Developed a multi-site data SharePoint for the Pre-Press department to streamline and organize the flow of information and data exchange; cartons, leaflets, inserts, label. SharePoint allowed for real-time tracking of project status and items requiring attention. • Completed a swim-lane process map of the Pre-press workflow to increase efficiency and eliminate waste utilizing lean six-sigma tools Commercial Packaging • Production Coordinator for Pouch & Biotechnology business units at pharmaceutical contract manufacturing, FDA regulated cGMP facility • Tasked with high levels of accountability in areas such as quality, manufacturing, packaging, project management, and operational excellence • Utilized OpEx to increase profit over a three-month period in Biotech packaging suite; increased profitability & throughput with standard work training; increased on time delivery. Business was retained due to decreased variations and improved reliability of supply. • Kaizen Leader Training- Operational Excellence • Attended communication, collaboration and conflict management training

• Cross-functional team experience with Operations, Purchasing, Marketing, Product Development • Experience working with outside material suppliers (Carton, Foam, Blister Tray, Pouch) • Performed extensive testing using; Vibration, Drop, Peel, and Burst equipment • Skilled in writing OQ and PQ protocols and reports. Attended ISO-11607 Seminar

• Justification written to allow for material change from PVC->PETG • Testing of packaging system to determine feasibility. Parallel path to ensure project completed in accordance with timeline. • Cost saving initiative: Changed from coated to uncoated Tyvek