better, longer. For more information, visit us at . About the Role Director CMC, Program Management As the Director CMC... effort on filing New Drug Applications (NDAs) is a must. The Director, Program Management, will also have demonstrated...
better, longer. For more information, visit us at . About the Role Associate Director, CMC Drug Substance Development... and Manufacturing As the Associate Director, CMC Drug Substance Development and Manufacturing reporting to the Senior Director of CMC...
of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient... and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities...
of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, GRA CMC Small... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. How you will contribute: Plan...
including asset strategy, development, supply and life cycle management planning for the commercial program. This PO&T Asset...About This Role The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead...
leadership and program management for multiple global CMC development teams dealing with complex development programs... audience. Can represent CMC viewpoint at corporate and industry level. Resource Management - ability to anticipate and manage...
Job Description General Summary: This Commercial Manufacturing and Supply Chain (CMSC) Director Project Management... strategies within the Heme program. The position will work with the CMSC and CMC leads and interface directly with CDMOs...
Job Description General/Position Summary The Director, CMC Inspection Management as part of the Vertex Quality... Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site...
and support of Vendor Management processes within CMC Quality. This position reports to: Director, Small Molecule CMC Compliance... with External Partners. Ensures that all the documentation associated to the Vendor Management program; risk assessment reports...
Job Description Position Summary The Director, Product Quality for the Biologics and Device Quality organization... is accountable for end-to-end quality oversight of Biologics and Combination Device program(s) throughout clinical development...
Job Description General Summary: The Director, Analytical Sciences and Technology (Small Molecule Drug Product... and external settings. The director provides technical and strategic leadership across global test sites for analytical, process...
Job Description General Summary: The External Manufacturing Director Cell and Genetic Therapies, role is to oversee... clinical through post-approval lifecycle management. The right candidate will understand the challenges and make proactive...
Job Description The Product Quality Director is accountable for end-to-end quality oversight of small molecule... program(s) throughout clinical development, commercialization, filing, approval, launch, and post approval lifecycle...
Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program... better, longer. For more information, visit us at . About the Role Director, Regulatory Labeling As the Director, Regulatory...
, Technical Operations, Supply Chain and others within Quality Assurance. This position reports to the Associate Director, CMC... expertise and project management of inspection readiness, as well as provide support during inspections. This role is recognized...