, for each other, and for the future of science, we're in. Are you? About the Role: The Sr. Director CMC QA will lead QA CMC oversight for drug... of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development...
how they contribute to the success of the organization. Summary of Position: The Sr. Director/Executive Director, Quality Control... as defined by US, EU and rest of world regulatory authorities and guidance. The Sr. Director/Executive Director, Quality...
quality assurance and continuous process improvement program including quality monitors, incident reports, corrective actions.... · Supervises daily and technical operations and quality management activities for the division. · Supervises the work...
closely with Quality Assurance function to develop and operate appropriate CMC procedures, and to ensure product meets... biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do Sr. Scientist/Associate Director...
drug product disposition. You will also work with colleagues in CMC, Supply Chain Operations, Quality Assurance, and CMC... & provide input to root-cause analysis and CAPA plans Participate in process confirmations, change controls, & quality...
management, quality assurance, compliance, communications and collaboration with different functional teams across the portfolio... and to execute SOWs in a timely fashion. Coordinate with CRO study director to initiate the internal reviewing process of draft...
are maintained according to corporate standards Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion.../Sr. Director Analytical R&D will support the development and registration for pre-clinical and late stage pharmaceutical...
and components applied in CMC development and clinical trial material production. Operational Excellence, Quality Assurance... and knowledge of the supply chain as well as compliance industry practices to perform the role effectively. The Sr. Director...
with Global CMC Development, external CDMOs, Manufacturing, Quality Assurance, Quality Control, and other stakeholders to enable... to support both early- and late-stage AAV GMP manufacturing at internal and contract gene therapy facilities. Reporting to the Sr...