Chris McKenzie, PMP

This position has allowed me to showcase my business management and technology development skills. I coordinate and oversee cross-functional technical teams, including other project managers, to solve the most significant technical challenges facing our clients in the pharmaceutical, biotech and medical device industries. I provide strategic counsel and mentorship to 20+ engineers and 7 project managers while directing the design, prototyping, verification, validation, and manufacturing transition of all products. My experience spans the entire product development continuum from early stage consulting and concept development, through commercialization, launch and into manufacturing. Here are some of my accomplishments that demonstrate my expertise in business and technology development: • Spearheaded the development and launch of internationally award-winning auto-injectors enabling a Battelle client to sell millions of devices contributing to a better quality of life for individuals with diabetes. • Strengthened company long-term growth potential by creating a licensing strategy for drug delivery device technology for a major pharmaceutical client. • Generated $12MM in revenue in 2017 by serving as a program manager and an advisory board leader for 20+ programs. • Saved a failing $15MM electro-mechanical system program by resetting client expectations, improving communications, and implementing robust change management resulting in successful product verification and regulatory submission.

My mandate in this role was to lead product development and project management for multi-million dollar pharmaceutical delivery system projects that lasted between 2-5 years per project. I was responsible for leading these development programs from advanced development through commercial launch in a highly regulated device development environment. Here are some of the noteworthy products that we developed during my tenure: HumaPen Memoir, HumaPen Luxura, HumatroPen 3, HumatroPen MG and HumatroPen II pen-injector products for insulin and growth hormone therapies. My responsibilities included the execution Product Concept Development, Project Planning, Prototype Development, Verification and Validation, Regulatory Submission Support, and Manufacturing Planning. Key activities included developing staff plans, creating expense and capital budgets, developing project plans (timelines and deliverables), creating test plans, performing risk analysis (Hazard, DFMEA, PFMEA, and AFMEA), releasing tooling, managing third-party development and manufacturing partners, supporting regulatory submissions, and managing clinical trial activities. As a result of the improvements that I made to product development and manufacturing I was recognized with the Eli Lilly Changing the World and Quality Advocate awards.

In this role I led manufacturing engineering and project management for disposable skin stapler and breast biopsy production lines. I improved manufacturing quality by implementing 3-D modeling for injection molded and stamped metal device components, and also boosted manufacturing yields by instituting assembly line process parameters for ultrasonic welding, pad printing, and heat sealing equipment.

I managed a team of 25 manufacturing employees focused on injection molding, assembly, and painting of automotive components. By implementing continuous improvement best practices we were able to consistently meet our production goals with high customer satisfaction regarding product quality.