RMC Pharmaceutical Solutions, Inc. Expands Its Global Expert CMC Services Team

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RMC continues to bolster its industry-leading expert services team with the addition of two senior industry professionals who bring extensive experience in bio-pharmaceutical process development and manufacturing support, CMC regulatory filings, large-scale pharmaceutical API production and drug product packaging.

RMC Pharmaceutical Solutions, Inc. enhances its global expert services team with the addition of Duane Bonam and Molly Sherrard as senior consultants.

Duane brings over 25 years of experience in bio-pharmaceutical process development, manufacturing support, and global CMC regulatory filings including marketing applications and post-approval changes. His expertise is with the development, scale-up and improvement of investigational and commercial manufacturing processes, process characterization, qualification and verification and QbD, viral clearance and safety issues; as well as authorship and technical review of CMC sections in regulatory filings. 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. Prior to Amgen, Duane was at Wyeth (formerly Genetics Institute) where he helped develop the purification process for recombinant Factor IX and provided ongoing commercial life-cycle support. Duane received his Ph.D. in biochemistry from the University of Wisconsin, and a B.S in chemistry/biochemistry from the University of Illinois.

“As RMC’s global reputation for excellence continues to grow, Duane brings valuable strategic and tactical CMC experience to RMC,” said Timothy Joy, President of RMC. “Duane’s depth of experience in highly successful programs, lets him hit the ground running with practical, knowledgeable hands-on execution and assistance that our clients have come to expect from RMC. Several of our staff have worked with Duane in the past, and we’re confident that he will fit in well with RMC’s “Bolt On” strategy for CMC development for all kinds of pharmaceutical and biological products”

Molly comes to RMC with over 18 years of pharmaceutical experience gained across technical and leadership roles at several large-scale API manufacturing and drug product packaging sites. Prior to joining RMC, Molly established her adaptive skillsets with successful roles as a production engineer, manager API manufacturing and operational excellence at Pfizer; and manager of packaging technology and project manager at Bristol-Myers Squibb and AstraZeneca. She also brings 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. Molly received a Bachelor of Science in Chemical Engineering from the University of Kentucky, as well as training in the Rath & Strong Method 4 Lean methodology and Project Management Professional certification from the Project Management Institute.

“Molly’s solid engineering background and technical project management leadership, which transcends both API manufacturing and drug product packaging systems, is exemplified in her cross-functional adaptability and expertise,” said Timothy Joy, President of RMC. “We expect that Molly’s broad background, commitment to success and her contemporary understanding of key global product packaging and commercialization challenges, will have an immediate positive impact on our RMC teams and the clients they support.”

About RMC Pharmaceutical Solutions, Inc.

Founded in 2004, RMC is the privately-held global leader providing Bolt-on CMC™ expert services to the pharmaceutical, biotechnology, medical device and allied industries. RMC was founded to provide comprehensive services to companies developing and commercializing health care products and has now served more than 150 different clients across North America, Europe and Asia. Through our Bolt-on CMC™ expert services offering, RMC provides an experienced integrated team to directly support Chemistry, Manufacturing and Control (CMC) areas such as process, analytical and formulation development; quality control/quality assurance; and oversight of GMP manufacturing. RMC experts also support the full range of pharmaceutical development and commercialization of GxP activities. Our clients have access to the considerable expertise of the RMC team, as well as physical assets; including an analytical and process development laboratory, document management, and advanced software tools.

For more information about RMC and how we can help you, please visit http://www.rmcpharma.com.

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Leticia Sanchez
@RMCPharma
since: 05/2017
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