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Meet our Experts

Blow-Fill-Seal Manufacturing

Philip Leslie, Sr. Advisor, Manufacturing
Philip Leslie, Sr. Advisor, Manufacturing

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.

Philip Leslie, Sr. Advisor, Manufacturing
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Jeff Price, Consulting Principal BFS Engineer
Jeff Price, Consulting Principal BFS Engineer

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.

Jeff Price, Consulting Principal BFS Engineer
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Jon Burgess, General Manager, Technology Development Center
Jon Burgess, General Manager, Technology Development Center

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.

Jon Burgess, General Manager, Technology Development Center
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Dave Boerschel, Program Director, Blow-Fill-Seal
Dave Boerschel, Program Director, Blow-Fill-Seal

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.

Dave Boerschel, Program Director, Blow-Fill-Seal
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Todd Gifford, Blow-Fill-Seal Operations and Training Manager
Todd Gifford, Blow-Fill-Seal Operations and Training Manager

Mr. Gifford’s role as Blow-Fill-Seal Operations (BFS) and Training Manager 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 designing, prototyping, and fabrication of components and prototype molds. In addition to the operation of BFS equipment, Mr. Gifford provides internal and external training, on the BFS process, including mold making.

Todd Gifford, Blow-Fill-Seal Operations and Training Manager
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Design, Development, and Combination Products

Lauren Greenberg, Vice President, Device Development
Lauren Greenberg, Vice President, Device Development

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.

Lauren Greenberg, Vice President, Device Development
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Stephanie Summe, Sr. Director, Combination Product Development
Stephanie Summe, Sr. Director, Combination Product Development

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, including combination products.

Stephanie Summe, Sr. Director, Combination Product Development
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Emily Schimek, Sr. Director, Device Development
Emily Schimek, Sr. Director, Device Development

At ApiJect, Ms. Schimek leads the team to establish and execute plans to develop product requirements, product designs, and execute design verification and validation activities. She is responsible for ensuring the performance and quality of ApiJect’s development process complies with quality management, regulations, standards, and agency guidelines.

Emily Schimek, Sr. Director, Device Development
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Laura Weidner, Senior Director, Corporate Development
Laura Weidner, Senior Director, Corporate Development

Laura Weidner brings more than 20 years of hands-on experience developing and managing functional teams, inclusive of engineering, new business, operations, finance, and quality assurance and control. She leads complex and innovative projects across ApiJect, driving projects through early life cycle by developing and tracking through project plans and scope.

Laura Weidner, Senior Director, Corporate Development
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Global Access

Paul Rutter, MD, SVP, Clinical Affairs
Paul Rutter, MD, SVP, Clinical Affairs

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.

Paul Rutter, MD, SVP, Clinical Affairs
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Operations / Supply Chain

Josh Myers, Vice President, Distributed Manufacturing & Supply Chain
Josh Myers, Vice President, Distributed Manufacturing & Supply Chain

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.

Josh Myers, Vice President, Distributed Manufacturing & Supply Chain
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Pharmaceutical Services

Joe Wojcik, MBA, PMP, Senior Director, Pharmaceutical Development Services
Joe Wojcik, MBA, PMP, Senior Director, Pharmaceutical Development Services

As leader of the Pharma Development Team, Mr. Wojcik is responsible for overseeing the successful completion of client development projects, from lab-scale early phase through late-stage development. In addition, he manages client engagement and provides support for combination device programs, including non-GMP feasibility, drug product formulation and compounding, and business planning to help clients achieve their goals.

Joe Wojcik, MBA, PMP, Senior Director, Pharmaceutical Development Services
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Process Development & Packaging

Christian Eichhorn, Vice President, Packaging and Process Development
Christian Eichhorn, Vice President, Packaging and Process 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.

Christian Eichhorn, Vice President, Packaging and Process Development
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Michael Buzecky, Senior Director, Process Development & Packaging
Michael Buzecky, Senior Director, Process Development & Packaging

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.

Michael Buzecky, Senior Director, Process Development & Packaging
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Quality / Project Management

Amanda Jung-Si-Nae Barrick, PCQI, Senior Director of Quality
Amanda Jung-Si-Nae Barrick, PCQI, Senior Director of Quality

With over twenty years of experience in the medical device industry focusing on Quality Systems and Quality Engineering, Amanda Barrick has a successful track record of product launches, audit outcomes, and change management. As the leader of quality activities at ApiJect, she provides compliance oversight for medical devices, combination product development and manufacturing processes. Additionally, she fosters a culture of quality within the organization.

Amanda Jung-Si-Nae Barrick, PCQI, Senior Director of Quality
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Regulatory

Ashley Dynan, Sr. Director, Regulatory
Ashley Dynan, Sr. Director, Regulatory

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.

Ashley Dynan, Sr. Director, Regulatory
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Additional Technical Resources

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