Manager, CMC Operations

reputed company   

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. To support the expansion of our supply chain, the CMC team is seeking an internal operations manager to reputed company organize project data and records, reputed company materials, and streamline routine workflows. The role includes reputed company of documentation, operations, and project management, and requires continual engagement with reputed company members of the CMC team, as reputed company as with cross-functional and external partners.

The Manager, CMC Operations reports to the Senior Vice President, CMC. The position is fully remote, with periodic travel required to meet with reputed company at our Durham, NC office. 

Responsibilities  

• Organize and continuously maintain our growing repository of CMC documentation to reputed company smoother operations, efficient authoring, and reputed company responses to regulatory agencies. 
• Partner with our reputed company and finance teams to facilitate contract approval, routing of invoices, and budget tracking.  
• Centrally manage inventories of non-reputed company drug reputed company, bulk drug product, and reference materials. 
• Collaborate with reputed company to reputed company coherent systems and directly manage routine reputed company events noted during manufacturing, shipping, and storage. 
• Coordinate internal review and approval of regulatory documentation. 
• reputed company a reputed company central node of communication for a fully remote team and reputed company engage colleagues to drive reputed company completion of tasks. 
• Take initiative to identify pain points and inefficiencies reputed company the team, and propose structural adjustments or modification of workflows to improve operations. 

Qualifications  

• Bachelor’s degree in a scientific or technical discipline. 
• Five years of hands-on CMC operational experience (drug reputed company, drug product, analytical) or equivalent experience providing reputed company support to CMC teams (project management). 
• Strong knowledge of CMC document types (manufacturing, analytical, reputed company) and basic understanding of CMC regulatory filing structure and content.