Newark, Del., October 26, 2021 – The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce that Jeffery Baker, Ph.D., Tim Charlebois, Ph.D., Roger Hart, Ph.D., and Stefanie Pluschkell, Ph.D. have recently joined the Institute as NIIMBL Senior Fellows enhancing that expertise of the organization with an additional 100 years of industry experience.
“I am excited to announce our new Senior Fellows whom all bring unique insight and expertise to NIIMBL,” shares Kelvin Lee, Institute Director. Lee adds, “As we continue to grow, only 5 years since our launch, the importance of having broad-based perspectives from industry thought-leaders is critical to our community and mission.”
NIIMBL is catalyzing advanced manufacturing innovations and workforce development with a membership composed of academic, industry, and non-profit stakeholders working with relevant government agencies. The NIIMBL Senior Fellows play key roles in leading various Institute initiatives such as our Process Intensification Program, Big Data Program, and Regulatory Considerations Committee, among others.
Meet the Senior Fellows:
Dr. Jeff Baker is a cellular physiologist and biochemist by training. He spent over 20 years in the pharmaceutical industry supporting the development and manufacture both legacy and first in class biological products and 10 years at the United States FDA as Deputy Director of the Office of Biotechnology Products in CDER. In the latter role he received several CDER awards for his role in renewing and rebalancing OBP review, inspection, and research programs and in 2018 received an FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology products through sustained creative leadership and collaboration.” He was the CDER liaison to NIIMBL and the Advanced Manufacturing National Program Office at NIST. He retired from the FDA in 2021 but remains active in the biotech community and is a frequent speaker at professional conferences and a number of university programs.
Dr. Tim Charlebois retired from Pfizer after a 30-year career with the company including legacy companies Wyeth and Genetics Institute. His technical expertise and experience included molecular biology, cell line development, characterization, cGMP cell banking and testing, cell culture and drug substance process development. He was deeply involved in the development and registration of a number of early biopharmaceutical products including Recombinate (rhFVIII), BeneFIX (rhFIX), Neumega (rhIL-11), Infuse (rhBMP-2), ReFacto AF (BDDFVIII), and Enbrel (etanercept). As VP of Technology & Innovation Strategy for Biotherapeutics Pharmaceutical Sciences, he was responsible for building new business processes and a network of leaders across the organization in the areas of technology strategy and platforms, external collaborations and alliances, in- and out-licensing due diligence and business development as well as external disclosure and intellectual property. He provided leadership to Pfizer’s transition into cutting-edge modalities, first with the CAR-T venture that eventually became Allogene and later with the company’s major investment into AAV-based gene therapy.
Dr. Roger Hart joins NIIMBL with 30 years of experience in the biopharmaceutical field having focused on process development spanning pre-clinical molecule selection through commercial process implementation and support for protein therapeutics. Prior to joining NIIMBL, Dr. Hart was Scientific Director Process Development at Amgen responsible for external scientific collaborations within the Academic Interface and external outreach programs to universities and technology incubators. Earlier, he advanced numerous products (mAb, pepti-body, protein, small molecule) and technologies as part of the management and scientific staff at Amgen and Genentech.
Dr. Stefanie Pluschkell has over 20 years of experience in the biopharmaceutical industry. She is the Founder and CEO of InScope Coaching & Consulting LLC, providing executive leadership and career coaching as well as consulting services to corporations, academic institutions, non-profit scientific organizations, and individuals. In her most recent biopharmaceutical industry role, she was the Executive Director and Head of Business Strategy and Operations for Biotherapeutics Pharmaceutical Sciences at Pfizer Inc. In this role, she led the execution of strategic and annual business plans via matrix leadership across pharmaceutical sciences, worldwide research & development, commercial business units and manufacturing. She supported a highly diverse product portfolio, including vaccines, monoclonal antibodies, other therapeutic proteins, and advanced therapies such as gene therapy. Stefanie’s team managed all laboratory and GMP facilities across the biotherapeutics pharmaceutical sciences network globally and provided the digital transformation strategy.
To learn more about NIIMBL, visit niimbl.org.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members.
Maria X. Chacon
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