RMC team members have a wide knowledge base across the pharmaceutical and related biomedical fields. Biographies of only a few RMC personnel are provided below, but there are other specialists available to assist with your project needs. Beyond the limited biographies presented below, there are additional RMC personnel with experience in Quality Assurance/Quality Management Systems; GxP Contractor Oversight Programs; Analytical/Quality Control; CMC Regulatory; Clinical and Commercial Supply Chain; Commercial Complaint Handling; Training Programs; GxP Audit and Qualification programs; Regulatory Inspection Preparation and Remediation Programs; Quality Agreement Negotiation and Manufacturing Process Optimization.
Commencing his pharma/biotech industry career in 1980, Tim now serves as the President/CEO of RMC Pharmaceutical Solutions since helping to co-found RMC in May 2004. He also draws from this broad global industry experience to assist multiple clients by serving as their senior/executive quality management official. In these embedded roles, Tim helps these companies to create, develop, execute and achieve their own measured solutions for the interrelated development, compliance, quality and project integration responsibilities of both clinical/product development and commercialization programs. With contemporary hands-on experience evaluating, monitoring, directing and/or executing GxP quality systems and activities across Asia, the Americas and Europe, Tim possesses a uniquely current and global perspective. He regularly utilizes this perspective to balance and achieve the varied compliance, quality and overall drug development/commercialization objectives of numerous organizations throughout these key global regions.
Scott joined the pharma/biotech industry in 1989, and has served as the Chairman/COO of RMC Pharmaceutical Solutions since helping to co-found the company in May 2004. Scott has been involved in a wide variety of projects for small and large biotech/pharmaceutical companies, including serving in multiple embedded senior/executive management roles. He has also 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 full-time position prior to co-founding RMC, 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.
Duane Bonam has worked with biopharmaceutical process development, manufacturing support, and global CMC regulatory filings including marketing applications and post-approval changes since 1990. His expertise is with the development, scale-up and improvement of investigational and commercial manufacturing processes, process characterization and QbD, viral clearance and safety issues; as well as authorship and technical review of related CMC sections. Before joining RMC Duane was at Amgen for over 15 years. As a Scientific Director he supported late-stage development and commercial processes, implementation of QbD, and participated in the FDA QbD pilot program. He authored or edited CMC sections of six BLA submissions and numerous supplemental filings. Prior to this, Duane was at Wyeth (formerly Genetics Institute) for 7 years where he helped develop the purification process for recombinant Factor IX and provided ongoing commercial life-cycle support. Duane started his career at Synergen where he helped design purification processes for several early stage development products. Duane received his Ph.D. in biochemistry from the University of Wisconsin, and a B.S in chemistry/biochemistry from the University of Illinois.
Gary Camblin has been in the analytical world of the large molecule pharmaceutical industry since 1996, working with cytokines, monoclonal antibodies and oligonucleotides. He began his career at Amgen, where he developed expertise in fundamental laboratory techniques, chromatographic and separation method development, qualification, transfer and validation, and biochemical characterization of proteins and glycoproteins. From 2007 to 2016, Gary was an Attribute Sciences Team Leader at Amgen, responsible for product specific technical leadership, stewardship and management of commercialization, commercial support and analytical lifecycle projects. In this role, he worked very closely with various cross-functional partners and stakeholders such as: Process Development to guide and support development or change initiatives; Product Quality to define control strategies and determine comparability for post-approval changes; Quality Control for assay trending, improvement and validation; Manufacturing and QA during out of trend, out of specification or non-conformance investigations; Regulatory Affairs for authoring, editing and reviewing CMC sections of IND/INDa, BLA and post-approval Briefing Document, Comparability Protocol, CBE, PAS and APR filings; and site Audit/Compliance functions in preparation for and during inspections. Prior to joining RMC, Gary was a QC Senior Scientist at Ophthotech, responsible for technical oversight, management and data review/audit of contract testing partners, in support of commercialization activities for a PEGylated oligonucleotide aptamer.
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 from the University of Denver, Denver, Colorado and a Yellow Belt Training Certificate from the Colorado Association for Manufacturing and Technology in Boulder, Colorado.
Since joining RMC Pharmaceutical Solutions in February 2020, Pablo has assisted with downstream process development for drug substance, including analytical work with SDS-PAGE, UV-Vis, SoloVPE techniques, process research in column chromatography, ultrafiltration/diafiltration, enzymatic cleavage procedures, and results analysis. Pablo has also reviewed analytical data, provided document management functions for QA, and assisted on transition analysis research for chromatography applications. Pablo graduated from the University of Colorado at Boulder with a Bachelor of Science in Chemical and Biological Engineering, and a minor in Applied Mathematics. As an undergraduate student, he worked in Dr. Whiting’s lab, which focused on the development of a biodegradable agriculture sensor, and in Dr. Bowman’s lab, which focused on the improvement of thiol-ene materials for dental use.
Sheri Glaub has been with RMC since 2010 and has been working in the bio/pharma industry since 1995, 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.
Katie Kurtz joined RMC in July 2020. She has been involved with projects that include risk analysis, criticality studies, software validation, water system qualification, filter validation, document management functions, and assisting with the purification process for drug substance. Katie graduated from the University of Colorado at Boulder with a Bachelor of Science in Chemical and Biological Engineering. At CU, she researched protein stability and the effects of mechanical shock on proteins.
Kirsten Lewus has worked in the biopharmaceutical industry since 2004, focusing on upstream process development in mammalian and microbial processes. Her expertise includes process characterization, scale up, and investigation, and technology transfer. Prior to joining RMC, Kirsten worked for Amgen for over 8 years supporting the development, characterization, and scale-up of multiple monoclonal antibody and fusion protein processes. She has also authored CMC sections of IND and BLA submissions for multiple programs, performed process and raw material risk assessments, authored systems and quality operating procedures, and supported process validation activities. She started her career at Merck in vaccine bioprocess development where she gained experience in manufacturing investigations and media development.
Kirsten received her M.S. in Biomedical Engineering from Tulane University in New Orleans, Louisiana, and her B.A. in Biology from the University of Colorado at Boulder, Boulder, Colorado.
Since joining RMC Pharmaceutical Solutions in June 2018, Jenae has been involved with a variety of pharmaceutical and biotechnology projects including: writing standard operation procedures, protocols, and technical transfer documents; performing IQ/OQ/PQ on equipment for GMP use; providing document management functions for QC/QA; review of analytical data including batch production records and technical reports; assisting with process development and purification processes for drug substance; developing protocols and performing research on transition analysis on column chromatography and the implications to continuous processes; and performing investigations, deviation reports, and CAPAs.
Jenae Luellen graduated from the University of Colorado at Boulder with a Bachelor of Science in biological and chemical engineering in 2018. Her undergraduate research focused on development of protocols and troubleshooting of various antibody applications and assisting with in vivo and organ bath testing of protein hormones.
Suzanne Mecalo over 24 years of experience in FDA regulated industries including pharmaceuticals, medical devices, and food processing, with broad experience in quality, validation, planning and program development, metrology and calibration, and change control. Prior to joining RMC in 2019, Suzanne worked for 14 years as a contract service provider supporting large biotechnology capital projects, with a focus on change control and facilitation of cross-functional operations. She developed expertise in supplier quality auditing, risk assessment, equipment qualification, cleaning validation, and project management. Prior to that, Suzanne served as manager of calibration and validation at a start-up company, and quality laboratory manager at a large regional dairy processing plant.
Suzanne received her BA in biology from McKendree college in Lebanon, Illinois. In 2012 Suzanne secured Certified Pharmaceutical Industry Professional (CPIP) certification through the International Society of Pharmaceutical Engineers (ISPE), and in 2015 she received Certified Quality Auditor (CQA) status from the American Society for Quality (ASQ).
Raymond Nims has worked in the biomedical sciences since 1974. 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 board for the BioProcessing Journal; 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.
Deborah Quick has been with RMC since 2011 and has worked on mammalian and microbial processes in the biotechnology industry since 1991. Her technical specialization is in the area of cell culture and fermentation, including manufacturing of cell therapies. As a consultant, Deb has provided technical expertise to pharmaceutical, biofuels, and bio-based chemicals clients in the areas of process scale-up, technology transfer, and clinical/commercial manufacturing implementation and oversight. She has utilized her technical knowledge and analytical skills to design and analyze experiments for cell line and media development; process development, characterization and troubleshooting (DoE); process validation; plus facility design, commissioning, and startup. She has been actively involved in risk assessments (FMEAs), investigations/ CAPAs, preparing CMC sections of regulatory filings, vendor audits, and client audit preparations.
Prior to joining RMC, she was the Manager of Process Development at GlobeImmune and a Scientist in Process Development at SmithKline Beecham. Dr. Quick 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.
Timothy Reinhardt has worked in the pharmaceutical industry since 1992, including 18 years of quality leadership at Pfizer Inc, with the most recent role as the Director of Manufacturing and Supplier Quality Assessment. This group was responsible for the global quality compliance auditing program for contractors as well internal sites. His previous multifaceted pharmaceutical background is comprised of numerous quality activities in start-up, development and commercial stage organizations with various operations globally. His experience includes the regulations pertaining to gene therapy; sterile liquid, lyophilized and dry powder products; oral liquids; creams; tablets; transdermals; active ingredients and medical devices. In addition to his extensive experience on cross functional teams performing compliance assessments, inspection readiness and due diligences at various sites around the world, Tim was also the former leader of the Pfizer Site Auditor Training certification program as well as a member of the global data integrity assessment team.
Tim obtained his Bachelor’s Degree from the University of California, Davis, his Master’s Degree from San Francisco State University, as well as a professional certificate in pharmaceutical manufacturing from Stevens Institute. Tim will be serving RMC clients as both a Senior Consultant and Site Manager for the RMC North Carolina operations in the Raleigh area.
Leticia Sanchez has been accumulating experience in chemical and process engineering since 1998. 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.
Molly Sherrard has worked in the pharmaceutical industry since 1998. She has held technical and leadership roles at multiple API manufacturing and drug product packaging sites. She revamped the packaging technology department in her role as the manager to build a strong technical team and robust processes enabling exceptional performance. She has extensive experience with quality investigations, process improvement, new product launches, packaging line startup, general technical operations support and multiple implementation options to meet global product serialization expectations. Prior to joining RMC Molly succeeded as a production engineer, manager API manufacturing and manager operational excellence at Pfizer and manager of packaging technology and project manager at Bristol-Myers Squibb and AstraZeneca. Molly received a Bachelor of Science in Chemical Engineering from the University of Kentucky in 1998. She has been trained in the Rath & Strong Method 4 Lean methodology. She also earned a Project Management Professional certification from the Project Management Institute in 2014.
Emily Stites has worked in the biopharmaceutical and medical device industries since 2007. Her expertise includes process validation, process monitoring, commercial manufacturing support, and continuous improvement/lean manufacturing. She started her career at Amgen in process engineering supporting all aspects of commercial- and pilot-scale manufacturing of mammalian cell culture products. She also supported the successful validation and pre-approval inspections for a first-in-class oncolytic immunotherapy. Emily then worked for Cook Biotech in West Lafayette, Indiana, providing process engineering leadership for medical device manufacturing. Her responsibilities included resolving deviations, approving risk assessments, implementing process improvements, and executing process validation.
Emily received her M.S. in Biomedical Engineering from Purdue University and her B.S. in Chemical Engineering from Colorado State University.
Julie Struble has worked within the biotechnology field since 2002 and within the pharmaceutical industry since 2012. Prior to joining RMC, she was previously at Alder BioPharmaceuticals (now Lundbeck Seattle BioPharmaceuticals) where she held process engineering and scientist positions. Julie’s expertise is a fusion of chemical engineering, molecular biology, microbiology, genomics, fermentation, and statistical data analysis. She has experience in upstream process development, process scale-up and transfer, scale-down model development, and process troubleshooting. Julie has participated in production of biologics for clinical trial and commercial use. She is also familiar with drug product concepts and has served as person-in-plant for both drug substance manufacturing and drug product fill-finish activities.
Julie completed a postdoctoral fellowship at the National Renewable Energy Laboratory in Golden, CO. She holds a PhD in Chemical and Biological Engineering from the University of Colorado at Boulder and a BS in Chemical Engineering from Rutgers University. Julie is based in the Greater Seattle, Washington area.
Mark Tomusiak has worked in the biotechnology industry since 1991, 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.
Kerri Zawadzki has worked in the bio/pharma industry since 2002, 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 AstraZeneca), focused on integrating parenteral drug products and medical devices to ensure successful patient handling, and a Scientist at Cardinal Health, fill/finish, 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.