Philip Leslie has more than 30 years’ pharmaceutical manufacturing experience in Australia, New Zealand and the UK, chiefly with GlaxoSmithKline, and also with MSD and Eli Lilly.
Jeff Price brings over 29 years of pharmaceutical experience to ApiJect, specializing in all aspects of Blow-Fill-Seal aseptic fill-finish technology. At ApiJect, his main responsibilities include developing new products, with specific focus on designing, developing, and manufacturing Blow-Fill-Seal containers and how these containers attach to ApiJect’s needle hubs and medical devices.
With more than 17+ years of experience in pharmaceutical packaging, Jon Burgess oversees business and operational matters at the ApiJect Technology Development Center, including managing Blow-Fill-Seal and machine shop operations. The facility is focused in working with pharmaceutical companies to design, engineer, and test how to fill-finish injectable drug products in our scalable, single-dose prefilled injector.
Mr. Boerschel is a Program Management/Project Management professional with over 30 years of experience in sterile pharmaceutical manufacturing, packaging, high-tech electronic and food manufacturing industries. At ApiJect, Mr. Boerschel is responsible for managing multiple technical projects simultaneously, including new or enhanced products, engineering, cost containment and efficiency, and compliance initiatives for drug delivery and both clinical and commercial packaging.
Mr. Gifford’s role as Blow-Fill-Seal Opertaions (BFS) and Trianing Manger requires his highly technical knowledge of BFS equipment and supporting utilities. At our state-of-the-art Technology Development Center, he operates, maintains, and repairs BFS machinery for the design, prototyping, and fabrication of components and prototype molds. In addition to the operation of BFS equipment, Mr. Gifford provides training, both internal and external, on the BFS process, including mold making.
Ms. Greenberg leads Product Development at ApiJect. She brings 16 years of pharmaceutical industry experience to her role, focusing on the delivery of product designs and characterization data and methods, while providing strategic and technical direction for the combination product pipeline, and bearing primary responsibility for development, verification, validation, and advancement of ApiJect’s product portfolio. She also heads development of novel tools and processes to deliver on future product platform and licensee needs.
Ms. Summe leads the Device team of engineers supporting remediation, lifecycle management, and innovation of ongoing design and sustaining engineering activities related to the ApiJect Platform of drug delivery technologies. She establishes design engineering solutions as it relates to customer needs, product requirements, and the development of product designs. Additionally, Ms. Pierle is responsible for developing and maintaining Design History Files, ensuring that performance and quality of ApiJect’s development process complies with quality management systems, regulations, standards, and agency guidelines.
Ms. Pierle leads a team of ApiJect engineers responsible for providing an array of highly technical programs including the identification of user needs, product requirements, specification development, feasibility test development, design verification, validation testing, risk assessments, device creation and project team technical support. She establishes systems and practices for workflow improvement and enhancement of productivity.
Mr. Bort develops and tests new product designs, develops engineering solutions, and performs root-cause failure analyses specifically for sterile pharmaceuticals. By utilizing feedback and industry research/trends; he develops, builds, and verifies the functionality of product prototypes to help guide the Device team to develop drug delivery systems that truly make a difference.
Paul Rutter is a British public health physician who has specialised and worked extensively in global health. His focus has been on understanding the reasons why healthcare delivery is not working at the front-line level and addressing them through major global health programs.
Josh Myers is VP, Distributed Manufacturing & Supply Chain, at ApiJect. In this role, he is responsible for leading the planning and execution of global supply chain initiatives, including material logistics, procurement and managing relationships with key suppliers and external manufacturing partners.
Tony Wasilewski has 25 years of experience in the pharmaceutical industry with a majority of his career focused on the development, delivery, and launch of generic injectables. As Vice President of Pharma Development Services at ApiJect, He leads client engagement focusing on the “drug” aspect of combination device programs. Mr. Wasilewski and his team aid in the delivery of client development projects from lab scale early phase through late-stage development.
With over 17 years of experience in process and packaging development, Mr. Eichhorn heads these disciplines at ApiJect, defining strategy while directing and applying technical skills to programs and projects across the product development lifecycle.
Mr. Buzecky leads the process development and packaging team for the ApiJect’s Platform, helping to solve drug delivery challenges for sterile liquids. In this role, he is responsible for the development of required packaging design and other downstream processes including visual and particulate inspection for sterile products. Mr. Buzecky is also focused on emerging regulatory and compliance requirements as related to Blow-Fill-Seal manufacturing and packaging.
Lisa Fotheringham brings more than 27 years’ experience in pharmaceutical and laboratory support services to her role at ApiJect. She provides leadership for project management, processes, and resources to drive efficiency and effectiveness of all functions within Operations. Additionally, Lisa has launched regulatory functions within the organization to support the strategic objectives of ApiJect’s development programs.
Ashley Dynan brings 17+ years of pharmaceutical and medical device Quality Management Systems (QMS) and Regulatory Affairs experience to her role leading the ApiJect Regulatory Group. She focuses on developing and implementing regulatory strategies and processes for new and existing combination products and the ApiJect Platform.