Alex Tustian

Sr. Consultant

Alex Tustian has over 28 years experience in the pharmaceutical industry, gaining extensive experience in a variety of CMC roles.  Key highlights include management of contract manufacturing and other services, clinical supply chain logistics, authoring and reviewing manufacturing and CMC regulatory documents, and development of a variety of drug product formulations.  Prior to joining RMC in 2022, he has held responsibilities in clinical supplies production, packaging and distribution, formulation and process development and scale up, having served as Director in those areas at Sonus and Oncogenex Pharmaceuticals and PhaseRx.

Alex received his B.A in Biology from the University of Delaware.

Bennie Anderson

Project Specialist

Bennie Anderson joined RMC in March 2022 and has been a part of several project types, such as
environmental monitoring analysis, BLA quality control, and designing file organization systems for
manufacturers. In addition, RMC has provided training in various forms of GxP and writing standard
operating procedures/validation protocols for lab equipment.

Graduating from Colorado School of Mines in December 2021, Bennie received a Bachelor of Science in
Chemical Engineering and minors in both Chemistry and Biomedical Engineering. At Mines, Bennie
worked for the Environmental Health and Safety Department primarily in hazardous waste control,
earning OSHA HAZWOPER 40 certification as well as OSHA 30 General Industry.

Jake Black

Sr. Consultant

Jake Black joined RMC in 2022 bringing his significant knowledge across a range of chemistry fields including synthetic organic, natural products, medicinal, and nanomaterials chemistry. He is highly experienced with a variety of spectroscopic and analytical techniques, along with a background in scaling drug substance manufacturing from benchtop to pilot scale. Jake also has extensive experience in intellectual property (IP) and commercialization strategy from drafting patents and working closely with IP counsel, to managing IP portfolios.

Previously Jake developed his business and intellectual property expertise as a founding partner and CEO at TreeHouse Biosciences, a premier manufacturer of hemp-derived ingredients with a dual focus on advancing the scientific research of cannabinoids. Under his leadership, Treehouse rapidly grew from its ideation and inception in 2015 to a multimillion-dollar annual revenue generator, and became the first ASTM Certified CBD producer. Jake then oversaw the company’s successful exit via a merger with Next Frontier Brands in 2020, where he took the role of Chief Science Officer. As CSO he managed the intellectual property and R&D pipeline for beverage and natural product innovation from 2020-2022.  Jake brings his leadership, entrepreneurial spirit, and a variety of well-earned lessons learned from his start-up experiences.

Jake obtained his PhD in Organic Chemistry from Yale University as an NSF Graduate Research Fellow, and his B.S. in Chemistry with Honors from Villanova University.  His academic research focused on medicinal chemistry and the development of new spectroscopic methods, fields in which he has authored multiple papers.

Bill Wagner

Sr. Consultant

Bill Wagner has worked in the industrial and pharmaceutical biotechnology industries since 1999 gaining extensive experience in microbial fermentation and mammalian cell culture process development, scale-up, and scale-down.  While serving in various scientific and managerial roles at Amgen, AstraZeneca, and Novartis Gene Therapies, he became a leader in developing and implementing process characterization, process validation, and shipping validation strategies for biologics drug substance production.  Through these efforts, he also gained expertise in statistical design of experiment and data analyses, risk assessment facilitation, microbial control strategies, and authoring CMC sections of regulatory submissions aligned with QbD control strategies.  Bill began his career at Genencor International (currently International Flavors & Fragrances) developing biochemical fermentation processes and leading operations labs to support project goals and milestones.

Bill received an M.S. in Biochemistry from the University of Colorado-Boulder and a B.S. in Chemistry from University of Oregon.

Suzanne Mecalo

Sr. Consultant

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).

Deborah Galinis

Sr. Consultant

Deborah Galinis has worked in the pharmaceutical industry for almost 30 years.  Deborah has extensive small molecule drug development and CMC experience with successful cross functional team participation and leadership roles. Deborah received her Ph.D. in organic chemistry from the University of Iowa and her B.S. in chemistry from DePaul University. Deborah has significant experience in the authorship of worldwide regulatory submissions including North, Central and South America, Asia, South Africa, and Israel. She has excellent proven problem-solving talents and involvement with a wide range of manufacturing and formulation issues spanning from early development through commercial.

Libby Russell

Sr. Consultant

Libby Russell’s work experiences in the biotech industry had her leading product commercialization efforts overseeing analytical, tech transfer, validation, regulatory and process development activities. She has experience working on a range of products and modalities for both drug substance and drug product GMP manufacturing including monoclonal antibodies, oligomers and glyco-proteins. She received her Ph.D. in Chemical Engineering from the University of Colorado-Boulder studying protein aggregation in cell culture. Libby continued to work with the university as a lecturer in the Chemical Engineering department.

Jen Spencer

Sr. Consultant

Jen Spencer brings over 18 years of pharmaceutical experience, including extensive commercialization experience with peptide synthesis, recombinant proteins, monoclonal antibodies, and gene therapies. Her expertise is with process characterization, technology transfer, commercial manufacturing support including Process Validation/Continued Process Verification, process improvements, regulatory submissions, and project and program management. Prior to joining RMC, Jen held roles with increasing responsibilities within Process Development organizations at Amgen, AstraZeneca, and most recently as Sr. Manager MSAT at Novartis Gene Therapies. Jen received her B.S. degree in Chemical Engineering from University of Colorado, Boulder.

Kerri Zawadzki

Sr. Consultant

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.

Mark Tomusiak

Sr. Consultant

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.

Julie Struble

Sr. Consultant

Julie has worked within biotechnology areas for over 20 years.  Her experience is applying chemical engineering, molecular biology, and data analysis skills to solve an array of biotechnology challenges.  Her technical expertise is broad within process development, process characterization, scale-up, technology transfer, and process troubleshooting. She has worked with early and late-stage programs and has participated in several Regulatory Submissions.  Before joining RMC, Julie held roles in Process Development, Process Engineering, and Manufacturing Science &Technology at Lundbeck Seattle BioPharmaceuticals.

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 area.

Emily Stites

Sr. Consultant

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.

Molly Sherrard

Sr. Consultant

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.

Leticia Sanchez

Sr. Consultant

Leticia Sanchez has been accumulating experience in chemical/process engineering and pharmaceutical projects since 1998. She has worked in pharmaceutical and medical device Production, Quality Assurance (QA) Management, Process/Facility Design and Installation.

Leticia has worked as a Project Manager, QA Associate Director, Process/Project Engineering Manager, and Scientist.  For example, she has served as Project Manager for large capital projects including design, construction support, installation/qualification for pharmaceutical manufacturing processes as well as their supporting classified cleanroom facilities;  Process Engineering Manager directing cross functional teams incorporating R&D, scale-up, and engineering design for first of a kind enzymatic hydrolysis/fermentation plant; and QA Associate Director managing QA activities, including QMS/EQMS development, investigations, vendor qualification, and other QA activities for early phase pharmaceutical and combination product companies.

Through these experiences she has gained a broad understanding of the regulated pharmaceutical and allied industries in the United States, Europe, Australia and Asia.

Leticia attended the University of Colorado at Boulder where she earned B.S. and M.S. degrees in Chemical Engineering, and the Georgetown University Executive Education Program earning a Project Management Certificate.

Deborah Quick

Sr. Consultant

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 and a regenerative medicine product. 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, both in upstream and downstream aspects of manufacturing. 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; environmental monitoring performance qualification and EM data trending; 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.

Raymond Nims

Sr. Consultant

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.

Jenae Luellen

Project Specialist

Since joining RMC Pharmaceutical Solutions in 2018, Jenae has been involved with a variety of pharmaceutical and biotechnology projects in product and process development, manufacturing, and quality assurance roles. Jenae has provided advice and execution for small and large pharmaceutical molecules in process development. She has developed and executed transfer of small-scale downstream manufacturing processes, prepared and purified therapeutic proteins for proof-of-concept research in drug delivery, performed advanced process modeling of upstream and downstream operations, and provided onsite support and oversight for manufacturing activities for GMP phase production. She has led several downstream unit optimizations and developed and optimized a patented chromatography capture process for recombinant protein. Her current ongoing research includes large scale chromatography and transition analysis to evaluate the implications to continuous systems.

Jenae has also provided a broad range of quality support including developing, implementing and maintaining several QMS and document management control systems. She has authored SOPs, protocols, policies, specifications, COAs, technical transfer documents and reports; performed IQ/OQ/PQ on equipment for GMP use; performed extensive investigations, deviation reports, and CAPAs; reviewed analytical data, batch records, technical reports, stability reports, IND and BLA submissions; performed vendor audits and reviewed questionnaires; developed training programs for multiple departments including CMC, clinical and manufacturing; and developed and executed facility environmental monitoring qualification plans and protocols.

Jenae graduated from the University of Colorado at Boulder with a B.S. in Chemical and Biological Engineering. Her undergraduate research focused on development of in vivo and organ bath testing of protein hormones to further analyze the effects for prevention of preterm labor.

Kirsten Lewus

Sr. Consultant

Kirsten Lewus has worked in the biopharmaceutical industry since 2004, accumulating experience in process development, manufacturing support, technology transfer, quality and CMC regulatory filings. Her expertise includes process characterization, scale up and technology transfer of mammalian and microbial processes, quality oversight and establishment of Quality Management Systems, and authoring and reviewing CMC sections of regulatory submissions for multiple modalities.

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 started her career at Merck in vaccine bioprocess development. She received her MS in Biomedical Engineering from Tulane University and her BA in Biology from University of Colorado.

Katie Kurtz

Project Specialist

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.

Sheri Glaub

Sr. Consultant

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.

Leah Choi

Consultant

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.

Gary Camblin

Sr. Consultant

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.

Duane Bonam

Sr. Consultant

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.