Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Inventory Management Regulatory Compliance Cross-Functional Collaboration Regulatory Compliance Budget Management Narcotic Counting Project Management Contract Management Analytical Procedures Pharmaceutical Product Management Technical Writing Organizational Structure Stakeholder Engagement Process Improvement

Other Skills

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Communication
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Virtual Collaboration
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Time Management
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Teamwork
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Proactivity
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Problem Solving

Roles & Responsibilities

Bachelor's degree in a scientific or technical discipline.
Five years of hands-on CMC operational experience (drug substance, drug product, analytical) or equivalent experience providing direct support to CMC teams (project management).
Strong knowledge of CMC document types (manufacturing, analytical, quality) and basic understanding of CMC regulatory filing structure and content.
Ability to work in a fully remote environment with periodic travel to meet the team at the Durham, NC office.

Requirements:

Organize and continuously maintain our growing repository of CMC documentation to enable smoother operations, efficient authoring, and timely responses to regulatory agencies.
Partner with legal and finance teams to facilitate contract approval, routing of invoices, and budget tracking.
Centrally manage inventories of non-commercial drug substance, bulk drug product, and reference materials.
Collaborate with Quality to develop coherent systems and directly manage routine quality events noted during manufacturing, shipping, and storage.

Job description

Overview  

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 actively organize project data and records, track materials, and streamline routine workflows. The role includes elements of documentation, operations, and project management, and requires continual engagement with all members of the CMC team, as well 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 the team at our Durham, NC office.

Responsibilities

Organize and continuously maintain our growing repository of CMC documentation to enable smoother operations, efficient authoring, and timely responses to regulatory agencies.
Partner with our legal and finance teams to facilitate contract approval, routing of invoices, and budget tracking.
Centrally manage inventories of non-commercial drug substance, bulk drug product, and reference materials.
Collaborate with Quality to develop coherent systems and directly manage routine quality events noted during manufacturing, shipping, and storage.
Coordinate internal review and approval of regulatory documentation.
Provide a vibrant central node of communication for a fully remote team and actively engage colleagues to drive timely completion of tasks.
Take initiative to identify pain points and inefficiencies within 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 substance, drug product, analytical) or equivalent experience providing direct support to CMC teams (project management).
Strong knowledge of CMC document types (manufacturing, analytical, quality) and basic understanding of CMC regulatory filing structure and content.