RMC Pharmaceutical Solutions Inc.
At RMC Pharmaceutical Solutions (RMCPS), we are ready to help you conquer your challenges
during
pharmaceutical, biotech and combination (drug/device) product development and
commercialization activities. The RMCPS team offers expertise in quality
and compliance systems, validation and calibration controls, product/process development and validation, strategic planning, due diligence, and project management.
The foundation and scope of this team expertise has been obtained through nearly
60 years of collective experience across start-up, development and
commercial-stage organizations.
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The RMC Pharmaceutical Solutions
core team, from left:
Joanne Izyk, Scott
Rudge, Timothy Joy and Terri Kurtz
About Us
Scott Rudge brings 14 years experience in the pharmaceutical industry,
and an additional seven years of research and development in bioprocessing, to the RMC
Pharmaceutical Solutions team. He is cofounder of RMC Pharmaceutical
Solutions Inc. (RMCPS), and serves as Chief Operating and Technology Officer. Scott received his PhD in chemical engineering from Purdue University in 1989. In his last position, Scott served as the Vice President of Operations at FeRx Incorporated, overseeing manufacturing, process and product development, analytical development, formulation,
facility design, construction and operation, and intellectual property. He is an adjunct professor of chemical engineering at the University of Colorado, a guest researcher at the National Institute of Standards and Technology, and co-author of a leading text book on
bioseparations. Scott has also worked at Amylin Pharmaceuticals Incorporated, Synergen Incorporated, and the National Institute of Standards and Technology.
Timothy Joy offers 24 years of pharmaceutical industry experience to the RMCPS team, having worked with American Home Products
(Wyeth-Ayerst), Amylin Pharmaceuticals, and FeRx Incorporated. He is
President and Cofounder of RMC Pharmaceutical Solutions Inc. Previously, as Senior Director of Quality Assurance and Quality Control
at FeRx Incorporated, Tim was responsible for overseeing the design, development, and implementation of all aspects
an integrated global corporate quality program. These included the full range of GxP
(GLP, GMP, GCP) activities supporting pre-clinical research, CMC/product development,
along with clinical and manufacturing operations required both for global phase III trials and commercialization preparation. Tim's background also includes direct experience in operations/manufacturing, validation (method, equipment, and process), analytical research, stability, and the medical device QSR for combination products. Additionally, with hands-on experience conducting GxP compliance audits and due diligence evaluations in Asia (including China), US (including Puerto Rico), and Europe, Tim
is able to share a uniquely global perspective as a co-founder of RMCPS and ultimately with its client projects.
Joanne Izyk joined RMCPS with approximately 10 years of pharmaceutical, horticultural, and science education experience. Immediately prior to joining RMCPS, Joanne was Senior Manager, QA/QC at FeRx Incorporated, where she was responsible for the supervision and management of Quality Assurance and Quality Control. These responsibilities included document control and training; master record approvals; batch record review and release; testing of raw materials, in-process, release, and stability samples; review and approval of equipment work orders; deviations and investigations; complaints; validation protocols/reports; and general corporate SOPs. Joanne also brings to RMCPS hands-on experience from both commercial and development-stage pharmaceutical companies in the areas of quality control (including HPLC and various wet chemistry and physical testing techniques), analytical research and stability, technical report writing, Laboratory Information Management systems, as well as the compliance and regulatory requirements covered by
Titles 21, 29, 40, and 49 of the Code of Federal Regulations. With her varied background, Joanne is prepared to serve clients with excellent attention to detail, attentive compliance and technology perspectives, and a commitment to execute timeline-driven objectives in a variety of project roles.
Terri Kurtz brings over 10 years pharmaceutical
experience to the RMCPS team. Most recently, she was the Associate Director of
Manufacturing at FeRx Incorporated where she oversaw microparticle production,
process development and validation and clinical trial logistics for the MTC drug
delivery technology and the associated magnetic medical device.
She is named on a patent for the development of ceramic based
microcarriers. Additionally, she
collaborated in the design and implementation of quality systems for manufacture
of drug and device. She held
manufacturing and process development positions at Synergen and Geneva
Pharmaceuticals. At Geneva, she served as technical support for solid dosage
manufacturing, process validation, equipment validation, and manufacturing
process development. Terri received her MBA from Regis University and a BS in
Chemical Engineering from the University of Colorado at Boulder.