Visit the RMC BlogStaff Biographies
The members of our staff have a wide knowledge base across the medical fields. Biographies of the full-time technical staff are provided below. We also employ several part-time staff to complement our expertise and assist when project demands are high.
Tim Joy
Beyond serving as President of RMC, Tim assists clients with creating, developing, and/or executing and achieving their own measured solutions to both the individual and interrelated compliance, quality and development responsibilities of product development and commercialization programs. Additionally, with contemporary hands-on experience evaluating and monitoring GxP quality systems in Asia , North America and Europe, Tim possesses a current global perspective of precisely what is taking place to balance and achieve the varied compliance, quality and overall drug development objectives of numerous organizations throughout these key regions.
Scott Rudge
Since co-founding RMC Pharmaceutical Solutions in May 2004, Scott has been involved in a wide variety of projects for small and large biotech/pharmaceutical companies. He has overseen and/or performed assay, equipment, sterilization, cleaning and process validation, formulation development, due diligence for a multimillion dollar investment, construction of a new GMP facility for tissue processing, and tech transfer for a major late stage biotechnology product. 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.
Raymond Nims
Raymond Nims brings over 35 years of experience in the biomedical sciences. From 2006 to 2009, Ray served in Amgen's Corporate Quality Control group, providing subject matter expertise in viral and mycoplasma testing of raw materials and products, and serving as business process owner for Amgen's global contract analytical testing lab outsourcing program. From 1994 to 2006, Ray directed laboratories at BioReliance performing viral safety, endotoxin, and cell line identity studies for biologics cell line characterization, raw material testing, and product lot release testing. From 1985 to 1994, Ray served as a Chemist at the National Cancer Institutes' Laboratory of Chemical Carcinogenesis, and from 1974 to 1985 Ray held a variety of technical and supervisory positions at Microbiological Associates, a contract research organization.
Raymond obtained a PhD in Chemistry (Chemical Toxicology) at The American University, Washington, DC, in 1993. He currently serves on the advisory boards for the International Journal of Toxicology, BioProcessing Journal, and the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB); served on the ad hoc advisory boards for USP chapters 1237, 1050, and 1050.1, and is a member of the International Cell Line Authentication Committee (ICLAC). He is a generalist in the Biomedical Sciences, with a publication list spanning a wide range of areas in Chemistry, Carcinogenesis, Biochemistry, Pharmacology, Toxicology, and Virology.
Sheri Glaub
Dr. Sheri Glaub has been with RMC since 2010 and has over 15 years of experience in the bio/pharma industry, with a focus on analytical development and quality control. She received her Ph.D. in Inorganic Chemistry from Texas A&M University and subsequently worked in Product and Analytical Development groups at Bayer, Geneva Pharmaceuticals (now Sandoz), Upsher-Smith, FeRx and Tapestry Pharmaceuticals. She was formerly Director of Analytical Development at Tapestry. Since joining RMC, Sheri has worked with a variety of biotech, pharma and medical device clients to develop and oversee analytical and bioanalytical programs and activities including method development, transfer and validation; stability; sampling plans; product specifications; reference standards development; cGMP audits and more. She has worked with a variety of therapeutics including recombinant proteins, oligonucleotides, and other small molecules (both synthetic and naturally derived) and has worked with products from early (pre-IND) through late (post-commercial) stages.
Deborah Quick
Deb brings over 10 years of experience in cell culture and fermentation process development. Her industry experience includes evaluating growth and production of various products in CHO cells, S. cerevisiae, and E. coli. She was formerly Manager of Process Development at GlobeImmune, where she spearheaded efforts to scale-up the yeast production process for commercial scale production. She received her PhD in Chemical and Biological Engineering from the University of Colorado at Boulder, MS in Chemical Engineering from Cornell University, and BS in Chemical Engineering from NC State University.
Deb's expertise in upstream process development includes media formulation, process optimization, process scale-up/tech transfer, bioreactor/fermenter troubleshooting, cell-based assay development, and optimization of harvest methods. In addition to upstream processing, Deb also brings knowledge of physiologically-based pharmacological modeling and drug delivery from degradable polymer systems (from her graduate studies).
Leah Choi
Since joining RMC Pharmaceutical Solutions in November 2006, Leah has been involved in various pharmaceutical and biotechnology projects such as: assisting with the execution of OQ/IQ protocols for a manufacturing clean room; writing standard operating procedures, protocols, and technical transfer documents; assisting in the development and manufacturing process for a pre-clinical drug product; executing QC/QA review of production batch records, raw analytical data, technical reports, stability reports, and regulatory filings; executing some project management tasks; assisting in the design, creation, and implementation of a quality system for a virtual biotech company; executing various document management tasks; and reviewing pipe and instrument drawings, requirement specifications, and functional specifications for a modular CIP system.
Prior to joining RMC, Leah attended the University of Colorado at Boulder, Boulder, Colorado and earned her B.A. in Biochemistry, with a minor in Chemistry. In 2009, Leah also received a Certificate of Good Laboratory Practices/Good Manufacturing Practices form the University of Denver, Denver, Colorado and a Yellow Belt Training Certificate from the Colorado Association for Manufacturing and Technology in Boulder, Colorado.
Dr. Kerri Zawadzki
Dr. Zawadzki has over 10 years of experience in the bio/pharma industry, with a focus on product development of proteins and peptides from phase I through commercial launch. She was formerly a Senior Scientist at Amylin Pharmaceuticals (now Bristol-Myers Squibb), focused on integrating parenteral drug products and medical devices to ensure successful patient handling, and a Scientist at Cardinal Health (now Catalent), focused on formulation and stability of protein and peptide products. Kerri received her Ph.D. and M.S. in Chemistry from the University of California San Diego and B.S. in Chemistry from Allegheny College in Meadville, PA.
Kerri's expertise in product development includes formulation, product compatibility studies, container closure selection, extractable and leachable studies, product performance, analytical method development and validation, biophysical characterization of proteins, and stability studies. She also has experience with medical device development, human factors, product instructions development, failure mode and effects analysis, and product complaints handling and quality systems.
Korben Knudson
Korben Knudson graduated with a Bachelor of Science in biological and chemical engineering from the University of Colorado at Boulder in 2013. His senior year thesis focused on protein formulation and stability using recombinant Human Growth Hormone throughout various freezing and drying cycles. His work received the Bronze Outstanding Undergraduate Research Award and his data was published in the Journal for Pharmaceutical Sciences. He has experience simulating the manufacturing process and evaluating the economic viability of an insulin glargine production plant for a small biotechnology company. Korben joined RMC in February, 2015 as a project specialist and assists the other members of the RMC team with their respective clients on a variety of projects.
Leticia Sanchez
Leticia Sanchez has over 15 years of experience in chemical and process engineering. She has worked directly in API production. She has also worked in facility process design for capital project installation at GMP and non GMP facilities. Before joining RMC Pharmaceutical Solutions, she served as the process engineering manager at Abengoa Bioenergy where she managed a team of 15 engineers and several subcontractors to develop a first of a kind enzymatic hydrolysis / fermentation based biofuels facility. In her various positions she has worked as a scientist, process / project engineer and project manager.
Leticia attended the University of Colorado at Boulder, Boulder, Colorado and earned B.S. and M.S. degrees in chemical engineering. She has also received a project management professional certificate from Georgetown University executive education program.
Maria Wik
Maria brings over 12 years of experience in the biopharmaceutical industry. She received her M.S. in Chemical Engineering from University of Colorado Boulder and B.S. in Chemical Engineering from Hogskolan Dalarna, Sweden. Maria subsequently worked in Process Development and Manufacturing groups at Amgen, Inc. in various roles.
Maria has broad experience with late stage commercialization activities of both E.coli and CHO cell processes both upstream and downstream. Maria's expertise with commercialization activities includes Technology Transfer, Process Scale-up, Process Troubleshooting, Process Characterization, Process Validation, Clinical and Commercial cGMP Manufacturing, Regulatory Filings and Regulatory Inspections.
Melissa Leifheit
Melissa brings over 10 years of experience in the biotechnology/pharmaceutical industry spanning a wide range of responsibilities within quality, development, regulatory and manufacturing organizations. Prior to joining RMC, Melissa was the owner and principal consultant of Leif Science, LLC where she provided clients with technical expertise in process development and generation of regulatory submissions. Prior to forming Leif Science, LLC, Melissa was a process development scientist at Amgen Inc. where she led upstream development and commercialization of E. coli processes. Melissa also worked as a QC microbiologist at Amgen Inc. where she was responsible for oversight of in-process testing of commercial products according to cGMP standards.
Melissa's background as both a development and quality control scientist bridges the gap between development and quality organizations. Her experience with upstream process development includes tech transfer and scale-up as well as process optimization and characterization. Her expertise in QC Microbiology includes microbial limits testing, environmental monitoring, water quality testing, disinfectant effectiveness analysis, cell bank stability testing, and microbial identification.
Melissa earned her B.S. in Microbiology from Colorado State University.
Mark Tomusiak
Mark has over 20 years experience working in the biotechnology industry, focused on the development and commercialization of therapeutic protein production processes. As owner and principal engineer at Tomusiak BioSeparations Consulting, he provided engineering expertise to biopharmaceutical and biofuels clients in the areas of process scale-up, technology transfer, and implementation into the clinical and commercial manufacturing environments. Prior to this, he was Director of Process Engineering at Amgen, where he was responsible for the process design of facilities and equipment necessary for commercialization of large-scale protein production processes. At Amgen as well as Synergen, Mark held a variety of engineering positions supporting the development of clinical and commercial production processes. He holds a B.S. in Chemical Engineering from the University of Saskatchewan and an M.S. in Chemical Engineering from the California Institute of Technology.
Mark's experience in bioprocess engineering includes both microbial and mammalian processes, from fermentation through bulk fill, and at scales from pilot through large-scale commercial. He has been responsible for scale-up, technology transfer and manufacturing support, as well as generation of regulatory filings and presentations to regulatory agencies. He has worked extensively with the process design of new facilities from conceptual through detailed design, as well as the design and start-up of bioprocess equipment. His technical specialization is in the area of primary product recovery, including centrifugal separation, depth filtration and cell disruption.