The Pharmaceutical Development and Manufacturing (PDM) Project Management Sr. Associate will be responsible for providing project management support to biologics and small molecule CMC teams under the guidance of Sr. Project Management staff. The full scope of projects assigned may range from Pre-IND through Commercial including Phases 1, 2, and 3. The Project Management Sr. Associate will be collaborating with the following groups: Drug Substance Process Development and Technical Operations, Formulation Process Development, Process Chemistry, Analytical, Quality Assurance, Devices and Packaging, Global Supply Chain, Outsourcing, Regulatory Affairs, Commercial Manufacturing, and the Global Development Team. The PDM Project Management Sr. Associate will manage multiple projects and other duties will include contributing to the PMO office initiatives. The Project Management Sr. Associate will be responsible for maintaining and tracking various project activities including: timelines, action items, resource plans and other project documents. Strong application of PM knowledge, skills, tools and techniques to all project work is essential.
Essential Duties and Job Functions:
- Project management of multiple project teams working under the guidance of Sr. Project Management staff
- Develop and manage detailed project timelines for CMC activities
- Monitors project execution and adjusts plans
- Facilitates project communications and documentation
- Collaborates with the team to resolve issues and organizes team to execute on the corrective actions
- Ensures project work complies with established practices, policies, and processes
- Contributing to PMO office initiatives
Knowledge, Experience and Skills:
- Minimum 6 years of relevant experience and a BA or BS or 4+ years of relevant experience and a MS or MBA. PMP certification preferred. Relevant experience consists of work in cross functional teams for biopharmaceutical/ pharmaceutical CMC development, GMP and regulatory affairs.
- Excellent organizational skills, capable of setting priorities and delivering on commitments while managing a high workload
- Strong communication skills (verbal, written, presentation)
- Experience in pharmaceutical project management, direct CMC PM experience preferred
- In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio, SharePoint, Teams and other reporting/tracking tools