Ryan Kramer Email and Phone Number
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Ryan Kramer is a Leader in Drug Product Design and Development; Vaccines, LNPs, Adjuvants, Biologics, Fill/Finish, early-stage through commercial development at AstraZeneca. He possess expertise in protein chemistry, protein expression, protein purification, biochemistry, life sciences and 24 more skills.
Astrazeneca
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Director, Vaccines & Immune TherapiesAstrazeneca May 2024 - PresentCambridge, Cambridgeshire, Gb
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Senior Director, Formulation DevelopmentVenture-Backed Newco Dec 2023 - May 2024
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Principal Scientist, Drug Product Design And DevelopmentPfizer Sep 2021 - Dec 2023New York, New York, Us• Drug product development lead in a highly-matrixed organization responsible for phase 1 though post-commercial support for antibodies, vaccines, and gene therapies.• Drug product lead for three exploratory phase 1 clinical studies leading to submission of two INDs and one IMPD. • Led the development of a multi-dose vial presentation for a commercialized vaccine from conceptualization through process validation and BLA/MAA authoring.• Established mRNA + LNP capabilities at the Chesterfield site. Recruited and led the tech transfer team in establishing analytical and fabrication methods including strategy, facility build-out, personnel training, and verification of site-to-site equivalence.• First LNP drug product lead at Chesterfield site with expected IND submission in 2024. • Member of the LNP regulatory document review team responsible for reviewing LNP regulatory filings for consistency across programs.• Member of a limited duration team focused on evaluating tissue-targeting technologies for gene editing using lipid nanoparticle and other delivery mechanisms. -
Associate Principal Scientist, Vaccine Drug Product DevelopmentMerck Jul 2020 - Sep 2021Rahway, New Jersey, Us• Phase 2 through line-of-sight to commercial drug product process development. • Led the development of robust commercial lyophilization processes for single and multi-dose quadrivalent drug product presentations that achieved VVM7 requirements for distribution to the developing world.• Tech transfer of drug product processes to domestic and international commercial manufacturing partners and development of FSS and PPQ strategies.• Drug product development lead for authoring and source mapping clinical trial applications including Phase 2 IND.• CMC due diligence drug product development lead for evaluation of external technologies to support potential acquisitions. -
Director, Process And Product DevelopmentInfectious Disease Research Institute Feb 2019 - Jul 2020• Managed a multidisciplinary team of twelve direct and indirect reports responsible for protein, RNA, VLP, and viral-vector vaccine development including bioprocess, formulation, and tech transfer to internal and external CMO sites. • Established self-amplifying mRNA vaccine platform including drug substance and drug product processes. • Developed and implemented new departmental formulation methodologies including Design of Experiments (DoE), high-throughput excipient screening (intrinsic fluorescence, extrinsic fluorescence, SLS), stress stability studies (shipping, photochemical, freeze/thaw, oxidative), and kinetic predictive storage stability modeling (AKTS-thermokinetics).• Responsible for CDMO management, site selection, due diligence visits, audit support, technology transfer, and manufacturing process oversite for cGMP activities including master cell bank (MCB), bulk drug substance (BDS), and final drug product (FDP) for recombinant protein-based pharmaceuticals.• Chaired a multi-institution CMC subcommittee responsible for vaccine development including analytical, formulation, process development, and management, site selections, and audits of CMOs, as part of the Global Health Vaccine Center for Innovation (GHVCI).• Program manager for departmental contract research and development projects including SOW writing, cost proposal development, timeline management, budget tracking, client communication, and technical project oversight. • Author of regulatory filings for CMC sections of multiple IND filings.
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Senior Scientist, Process And Product Development ManagerInfectious Disease Research Institute Feb 2016 - Jan 2019
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Scientist Ii, Characterization And Product Development ManagerInfectious Disease Research Institute Jul 2014 - Feb 2016
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Scientist I/ Analytics ManagerInfectious Disease Research Institute Aug 2012 - Jul 2014
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Postdoctoral ResearcherUniversity Of Kansas Apr 2011 - Oct 2012Lawrence, Ks, UsRuss Middaugh and David Volkin LabsDepartment of Pharmaceutical Chemistry -
Graduate StudentTexas A&M University Aug 2005 - Mar 2011College Station, Tx, UsJ. Martin Scholtz and C. Nick Pace LabProtein Solubility -
Reu Summer InternIndiana University May 2004 - Aug 2004Bloomington, Indiana, Us
Ryan Kramer Skills
Ryan Kramer Education Details
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Texas A&M UniversityBiochemistry -
Washington State University
Frequently Asked Questions about Ryan Kramer
What company does Ryan Kramer work for?
Ryan Kramer works for Astrazeneca
What is Ryan Kramer's role at the current company?
Ryan Kramer's current role is Leader in Drug Product Design and Development; Vaccines, LNPs, Adjuvants, Biologics, Fill/Finish, early-stage through commercial development.
What is Ryan Kramer's email address?
Ryan Kramer's email address is ry****@****dri.org
What is Ryan Kramer's direct phone number?
Ryan Kramer's direct phone number is +120638*****
What schools did Ryan Kramer attend?
Ryan Kramer attended Texas A&m University, Washington State University.
What skills is Ryan Kramer known for?
Ryan Kramer has skills like Protein Chemistry, Protein Expression, Protein Purification, Biochemistry, Life Sciences, Molecular Biology, Sds Page, Fluorescence, Uv/vis, Circular Dichroism, Fluorescence Spectroscopy, Hplc.
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