Bryan Castle Email and Phone Number

Responsible for the analytical strategy for the synthetic molecule commercialization organization. Direct engagement with delivery of the synthetic oncology portfolio, and people development leader.

-responsible for the analytical strategy for the small molecule commercialization portfolio (post-FHD to registration)-multiple NDA/MAA (small molecule and peptide), and responses to global questions from all markets-analytical strategy leader for multiple oncology breakthrough therapy projects with rapid development/approval timelines (FHD to first approval in ~ 3 years)-lead analytical strategy refresh project pan-Lilly (synthetic molecules to biomolecules), executed a transition plan that resulted in a split of synthetic and bio molecule analytical-publications and presentations on NIR for UDU as part of CM RTRt-engaged in ICH Q2(R2) and Q14 via PhRMA workgroup and as leader of ISPE-PQLI workgroup

-established integrated analytical team to enable drug product (DP) continuous manufacturing (CM) - PAT and off-line analysis-enabled advancement of automation approaches for drug product analysis including implementation of platform methods to speed drug development with limited resources-enabled installation in commercial manufacturing of RTRt for DP CM-talent recruitment and development, supervised a group of 5 senior scientists-enabled in license of multiple late stage assets-invited presentations/sessions at AAPS and IFPAC

-responsible for small molecule line extension programs – including drug product, process chemistry, engineering, analytical development resources (group of 16)-responsible for business owned knowledge management (KM) resources (group of 5)-responsible for chromatographic separation method development and analytical automation (group of 5)-complete oversight for post first in man studies through commercial installation and registration-in KM, sponsored an effort resulting in the ID of projects to enable data integration, aggregation, and enhanced search capabilities-partnered with external organizations to optimize automation, separations and IT tool capabilities

-responsible for small molecule drug product analytical development organization and business owned knowledge management resources (group of 48, 38% senior scientists) -complete oversight for post first in man studies through commercial installation and registration-led group through a 20% reduction in staff and orchestrated an integration of drug substance and drug product analytical organizations (technical and business process)-partnered with external organizations to optimize automation and IT tool capabilities

-responsible for physical and structural characterization department, a corporate resource for Eli Lilly (group of 34, 50% senior scientists)-high-end MS, NMR, surface science, material science/particle characterization, spectroscopy, thermal and chromatographic screening/development-grew pan-Lilly characterization support-led capital planning, and implemented instrument life cycle replacement strategies-led Lilly wide elemental impurity strategy team

•analytical project leader for multiple early and late phase, small molecule, drug product development projects•expertise in HPLC and spectroscopic method development with a focus on fast, efficient methods•established business processes and technical solutions that resulted in efficiency and transformational changes within the analytical sciences division•group leader

•analytical project leader for multiple early and late phase, small molecule, active pharmaceutical ingredient (API) development projects•generated analytical modules for NDA, IND, and CTA submissions•leader of chromatographic efficiency team which delivered a standardized method development routine for the analytical sciences division•group leader

•analytical project leader for multiple late phase, small molecule, active pharmaceutical ingredient (API) development projects•generated analytical modules for NDA, IND, CTA, and EU dossier submissions•leader of cross functional development quality system redesign team•supervision responsibilities

•method development, validation, and transfer experience with HPLC, GC, KF, UV/Vis, titrations, and compendia tests in support drug substance development•site leadership for implementation of a new chromatography data system•analytical support for process development and pilot plant campaigns•supervision responsibilities