Responsible for project management and planning of CMC-related product/process development activities, including new product development, analytical methods development/validation, process improvements, and product characterization. Will work with third parties when necessary (e.g., suppliers and CMOs). Other responsibilities may include support of budgeting, regulatory submissions, supply chain, and operational excellence projects. The position will lead or participate on cross-functional teams with Technical Operations, Quality, Regulatory, and other functions.
· Program management for all CMC projects
· Partner with Technical Operations, Quality, Regulatory, third-party suppliers, corporate partners, and other functions to develop and execute technical CMC project plans.
· Lead cross-functional teams through intensive schedule planning sessions to ensure appropriate identification of cross-functional project interdependencies.
· Contribute to overall CMC strategy and setting appropriate goals/milestones.
· Manage resource planning, risk management, contingency planning, project reporting, meeting priorities/agendas.
· Develop and use appropriate project management tools and reports, depending on the specific circumstances.
· Proactively identify issues, risks, and opportunities; make recommendations for improvement, mitigation, or changes; and facilitate resolution of issues.
· Work with multiple functions to prepare regulatory submissions or other correspondence with agencies.
· BS or MS in Biotech, Chem Eng, Biology or Chemistry; MBA and/or Project Management Qualification (PMI) a plus
· 10+ years of project management experience
· 6+ years industry specific project management (FDA regulated, biotech, pharma, medical devices)
· Broad CMC development experience in early and late stage development
· Experience managing both internal and external (CMO/CRO/CTL) CMC-related projects.
· Solid understanding of CMC development milestones from Phase I to commercialization.
· Current knowledge of FDA regulations, guidelines, policies; demonstrated knowledge of evolving regulatory CMC requirements.
· Ability to handle multiple projects and priorities with exceptional organizational and time management skills.