of CMC regulatory submission documents of high scientific and technical quality that are compliant with global regulatory... requirements. Implement well-defined, efficient processes for preparation, review and approval of these CMC sections. Plays...
analytical CMC content for INDs, IMPDs, NDAs, amendments, annual reports, briefing documents, and health-authority responses... Analytical Development on CMC program teams and communicate risks, recommendations, timelines, and resource needs to internal...
health-illness continuum and life span within protocols set forth and approved by both the Nurse Practitioner and CMC...
Leidos has an excellent opportunity for an Engineering Technician to work on the Cargo Mission Contract (CMC...
of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. Working knowledge... successful plans and processes to solve complex problems Leadership Activities: Work closely with team members across all CMC...
Leidos has an excellent opportunity for an Engineering Technician to work on the Cargo Mission Contract (CMC...
, we invite you to join us. The purpose of the Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) –CMC Platform Regulatory... Scientist role is to provide strategic, tactical, and operational regulatory CMC support across therapeutic modalities...
. We are seeking a highly motivated and detail-oriented Director, CMC (Chemistry, Manufacturing and Controls) to join our dynamic team...
) Global Biologics Development (GBD) group, the Senior Manager, Biologics CMC Project Management provides project management... leadership and operational coordination for assigned biologics CMC programs, workstreams, or cross-functional initiatives...
Leidos has an excellent opportunity for a Project Manager to work on the Cargo Mission Contract (CMC). In this position.... The team works with commercial software such as IBM Maximo, Microsoft (MS) Project, and MS SharePoint, in addition to CMC...