Manager, CMC Operations

<p><strong><span data-contrast="none"><span data-ccp-parastyle="Default" data-ccp-parastyle-defn="{"ObjectId":"272499da-5523-5969-b17c-4f82c0ce3910|1","ClassId":1073872969,"Properties":[469775450,"Default",201340122,"2",134233614,"true",469778129,"Default",335572020,"1",469777841,"Times New Roman",469777842,"Times New Roman",469777844,"Times New Roman",469769226,"Times New Roman",335551500,"0",335559740,"240",201341983,"0",335559739,"0",201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777843,"Aptos",201341986,"1",268442635,"24"]}">Overview  </span></span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="none"><span data-ccp-parastyle="Default">Priovant</span><span data-ccp-parastyle="Default"> is committed to developing therapies that address high unmet need in autoimmune disease. </span></span><span data-contrast="auto"><span data-ccp-parastyle="paragraph">To support the expansion of our </span><span data-ccp-parastyle="paragraph">supply chain</span><span data-ccp-parastyle="paragraph">, the CMC team is seeking an internal operations manager to actively organize </span><span data-ccp-parastyle="paragraph">project data and records</span><span data-ccp-parastyle="paragraph">, </span><span data-ccp-parastyle="paragraph">track </span><span data-ccp-parastyle="paragraph">materials</span><span data-ccp-parastyle="paragraph">, and streamline routine workflows</span><span data-ccp-parastyle="paragraph">. </span><span data-ccp-parastyle="paragraph">Th</span><span data-ccp-parastyle="paragraph">e role includes elements of documentation, operations, and </span><span data-ccp-parastyle="paragraph">project management</span><span data-ccp-parastyle="paragraph">, and requires continual engagement with all members of the CMC team, as well as with cross-functional and external partners. </span></span></p> <p><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"Calibri",469777842,"",469777843,"Calibri",469777844,"Calibri",201341986,"1",469769226,"Calibri",268442635,"22",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">The </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">Manager</span><span data-ccp-charstyle="normaltextrun">, CMC Operation</span><span data-ccp-charstyle="normaltextrun">s</span></span></strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun"> </span><span data-ccp-charstyle="normaltextrun">reports to the Senior Vice President, CMC. The position is fully remote, with periodic travel </span><span data-ccp-charstyle="normaltextrun">required</span><span data-ccp-charstyle="normaltextrun"> to meet with the team at our Durham, NC office.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Responsibilities</span></strong><span data-contrast="auto"> </span><span data-ccp-props="{}"> </span></p> <ul> <li><span data-contrast="auto">Organize and continuously maintain our growing repository of CMC documentation to enable smoother operations, efficient authoring, and timely responses to regulatory agencies.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> <li><span data-contrast="auto">Partner with our legal and finance teams to facilitate contract approval, routing of invoices, and budget tracking. </span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> <li><span data-contrast="auto">Centrally manage inventories of non-commercial drug substance, bulk drug product, and reference materials.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> <li><span data-contrast="auto">Collaborate with Quality to develop coherent systems and directly manage routine quality events noted during manufacturing, shipping, and storage.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> <li><span data-contrast="auto">Coordinate internal review and approval of regulatory documentation.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> <li><span data-contrast="auto">Provide a vibrant central node of communication for a fully remote team and actively engage colleagues to drive timely completion of tasks.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> <li><span data-contrast="auto">Take initiative to identify pain points and inefficiencies within the team, and propose structural adjustments or modification of workflows to improve operations.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> </ul> <p> </p> <p><strong><span data-contrast="auto">Qualifications</span></strong><span data-contrast="auto"> </span><span data-ccp-props="{}"> </span></p> <ul> <li><span data-contrast="auto">Bachelor’s degree in a scientific or technical discipline.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> <li><span data-contrast="auto">Five years of hands-on CMC operational experience (drug substance, drug product, analytical) or equivalent experience providing direct support to CMC teams (project management).</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> <li><span data-contrast="auto">Strong knowledge of CMC document types (manufacturing, analytical, quality) and basic understanding of CMC regulatory filing structure and content.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":259}"> </span></li> </ul>