What are the responsibilities and job description for the Senior Manager, CMC Project Management position at Priovant Therapeutics?
Overview
Priovant Therapeutics is committed to developing therapies that address unmet needs in autoimmune diseases. The Senior Manager, CMC Project Management will further this mission as an integral member of the pharmaceutical development team progressing our late-stage drug candidate through registration and commercialization.
Reporting to the Senior Director, Analytical Development, the role includes elements of project, operations, and documentation management. Responsibilities include mapping and tracking progress towards critical project milestones, coordination of internal and external activities, and comprehensive organization of project data and records. The position is fully remote, with periodic travel to the Durham, NC office required.
Responsibilities
Priovant Therapeutics is committed to developing therapies that address unmet needs in autoimmune diseases. The Senior Manager, CMC Project Management will further this mission as an integral member of the pharmaceutical development team progressing our late-stage drug candidate through registration and commercialization.
Reporting to the Senior Director, Analytical Development, the role includes elements of project, operations, and documentation management. Responsibilities include mapping and tracking progress towards critical project milestones, coordination of internal and external activities, and comprehensive organization of project data and records. The position is fully remote, with periodic travel to the Durham, NC office required.
Responsibilities
- Develop integrated timelines and track progress of all CMC activities, including manufacturing of drug substance and drug product, release and stability testing, packaging and labeling, and finished product distribution.
- Drive operational progress and decision making, identify interdependencies and risks, and actively communicate with team members to enforce timely decision making and operational progress.
- Organize and maintain a continually growing repository of CMC documents to enable smoother operations and efficient authoring of regulatory submissions.
- Track project deliverables at external partners and facilitate well-organized and timely exchange of information, including quality documentation, contracts, and analytical methods and data.
- Lead CMC team meetings and communicate with team members on an ad hoc basis to ensure clear understanding of near-term deliverables and timely follow up on action items.
- Collaborate with partners in other functional areas (Quality, Regulatory, Clinical Operations) to coordinate CMC deliverables.
- Bachelor's degree in a scientific or technical discipline, with preference for an advanced degree or equivalent combination of education and experience.
- Five years of experience in a CMC technical discipline (drug substance, drug product, analytical) or directly supporting CMC teams (program management).
- Demonstrated experience working with cross-functional teams, external research and manufacturing organizations, and consultants, preferably within the context of a small organization.
- Solid understanding of typical pharmaceutical development activities and timing, particularly as pertaining to regulatory submissions.
- Strong knowledge of CMC document types (manufacturing, analytical, quality) and basic understanding of CMC regulatory filing structure and content.
- Ability to overcome communication barriers and actively drive interdependent and time-sensitive activities across a fully remote team, including with external partners in Europe.
- Top-tier organizational skills and ability to optimize information, inventories, and processes.
- Desire to contribute leadership, independent judgement, and an enthusiastic attitude to our fast-paced and dynamic environment.
