Ryan Kramer Email & Phone Number

Kirkland, Wa, Us

Kirkland, Wa, Us

Cambridge, Cambridgeshire, Gb

New 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.

Rahway, 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.

• 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.

Lawrence, Ks, Us

Russ Middaugh and David Volkin LabsDepartment of Pharmaceutical Chemistry

College Station, Tx, Us

J. Martin Scholtz and C. Nick Pace LabProtein Solubility

Bloomington, Indiana, Us

Phd, Biochemistry

Education record