Subject Matter Expert Profiles
We don't want you to be out on an island after purchasing a product from us. As such, we include an optional 2 hours of one-on-one discussion time with our team of experts to ensure you have the know-how to properly implement your new SOP, training, or template. Ask questions, get advice, and glean market-leading knowledge and lessons learned from our team of subject matter experts in your exact field. Meet some of the folks you may get a chance to chat with below.
Should you need more customized services, please check out our Kymanox main site for more information. Kymanox is a premier professional services organization with a focus on project delivery. Our team provides life sciences clients with engineering, scientific, quality, and regulatory support. Leveraging our Kymanox Project Management Toolkit, our people and tools are tuned for commercializing late-stage development programs in biotechnology, pharmaceuticals, medical devices, and combination products.
Kymanox Expert Profiles
Nicole has vast experience in the biopharmaceutical and medical device industries and is considered a technical subject matter expert in topics such as biologic manufacturing scale-up and technology transfer, process validation, and design verification/validation. She has managed and provided technical
support for several gene therapy projects involving both early and late stage programs, including development work and CGMP manufacturing (e.g., tech transfers, scale-ups).
Michael Denzer is a seasoned Life Science executive with a wide range of commercialization experience. He is an expert in all aspects of medical device and combination product development for approval in the USA and Europe. Michael has been responsible for device strategy, program management, and engineering development of injectable devices, packaging, labeling, and associated user facing materials. He holds several patents for injection devices.
Learn more about Michael:
Burak Ucar, PhD
Senior Process Engineer,
Burak Ucar has led and supported projects including process design, facility design and build, equipment procurement, packaging design and development for commercialization of pharmaceutical products. He has experience in performing technology transfer and compliance gap assessments, developing new manufacturing control strategy procedures, and creating detailed product and process descriptions for medical device diagnostics and biopharmaceutical companies.
Nich Schill, PhD
Nick Schill has been involved with early phase pharmaceutical discovery, new entity formulation, process and analytical development, and technical support of Phase I/II/III clinical trials for biopharmaceuticals, autologous cell therapies and gene therapy development programs. He also has deep knowledge in the development of biopharmaceutical combination products and Class I/Class II medical devices, including development of regulatory and clinical strategies and submissions, external vendor and contract manufacturer management, and process and design validation.
Learn more about Nick:
Michelle Wall, PhD
Engineering Solutions Manager,
Michelle Wall brings technical knowledge of equipment validation, cleaning validation, combination product design, and deviation and root cause investigation. She brings over ten years of experience in project management and product development, with subject matter expertise in tissue engineering, cell culture assays and products (monolayer and 3D), microscopy, and laboratory applications for applying mechanical stimulations to cells and tissues in vitro.
Jason Miller has experience in a wide breadth of topics pertaining to the pharmaceutical sector, with a focus on medical device commercialization, design control, and operational control strategies. He specializes in commercialization technical leadership for medical devices and combination products, as well as program management. Jason has helped deliver new manufacturing capability for device platforms starting from requirements through process validation.