and SOPs. Experience and ability to support CMC sections of INDs is preferred Excellent verbal and written communication...
to manage contract changes within the Project Controls group of the Construction Management Consultant (CMC) team on a light...
to manage contract changes within the Project Controls group of the Construction Management Consultant (CMC) team on a light...
to drive adherence to regulatory frameworks and documentation. In coordination with the CCO, support the CMC equity program...
, and practical experience to perform this work and collaborate on CMC analytical development strategies Other duties as assigned...
characterization of drug candidates, support formulation and process development, and contribute to CMC development and regulatory... on cross-functional project teams and maintain accountability for analytical deliverables supporting CMC, process development...
) About the Role: Serve as a senior technical leader within Pharmaceutical Development, representing CMC project teams across the... partnerships, supporting technical transfer and manufacturing readiness. Represent CMC on cross-functional teams to deliver high...
with cGMP, safety, and regulatory requirements. The position works cross-functionally with teams across CMC, Technical... development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing...
experience in cell and/or gene therapy, a strong foundation in clinical regulatory strategy (vs. purely CMC), and preferably... closely with Clinical Development, Clinical Operations, CMC, Quality, and other cross-functional teams to ensure regulatory...
clearly. · Support the preparation, authoring, and review of Chemistry, Manufacturing and Controls (CMC) regulatory content... to Have · Experience authoring CMC regulatory submissions, specifically stability sections, shelf-life or retest-period justifications...