, antibody discovery, CMC, and computational teams to deliver optimized lead molecules into the pipeline. This is a full-time...
partners including Translational Medicine, CMC, Toxicology, Clinical Development and Regulatory to deliver on project...
. What you'll be doing The Director of Regulatory CMC is responsible for leading the strategic development and execution of global... Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across the company portfolio from early-stage discovery...
within CMC technical teams Conduct risk assessments, supplier evaluations, and manage post-approval changes related to raw... plus years of industry experience Deep knowledge of CMC processes for biologics or mRNA platforms, including technology transfer...
with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams...
to lead, coordinate, and drive cross-functional CMC activities supporting early-stage development programs. This individual... will help drive continuous improvement initiatives across CMC business processes, portfolio management, operational excellence...
programs from research toward development. Partner across discovery, platform, development, CMC, and other teams to advance... and CMC considerations. Broad scientific expertise across protein production, purification, characterization, and analytical...
the work of CMC field and office staff in accordance with the Authority's Construction Manual. Ensures and documents... that all CMC staff are trained on and understand the contract requirements. Acts as the focal point for all correspondence...
the work of CMC field and office staff in accordance with the Authority's Construction Manual. Ensures and documents... that all CMC staff are trained on and understand the contract requirements. Acts as the focal point for all correspondence...
presentations to technical and project groups. Contribute to the preparation and submission of CMC portions of regulatory... duties as needed to provide technical support for ongoing manufacturing. Provide technical support for all CMC activities...