Job Details

Pharmaceutical Development And Manufacturing (PDM) Project Management Sr. Associate

The Pharmaceutical Development and Manufacturing (PDM) Project Management Sr. Associate will be responsible for providing project management support to small molecule CMC teams under the oversight of Sr. Project Management staff. Primary responsibilities will include management of commercial programs and post approval life cycle management. The full scope of projects assigned may range from IND, Phase 1, 2, 3 to Commercialization. The Project Management Sr. Associate will be collaborating with the following groups: Process Chemistry, Formulations, Analytical, Quality Assurance, Packaging & Labeling, Global Supply Chain, Outsourcing, Regulatory Affairs, Commercial Manufacturing, and the Corporate Project Team. The 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.

Essential Duties and Job Functions:

• Project management of multiple project teams working under the oversight 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. Relevant experience consists of work in cross functional biopharmaceutical /pharmaceutical CMC development, GMP and regulatory affairs
• Excellent organizational skills, capable of setting priorities and delivering on commitments while managing high workload
• Strong communication skills written and verbal including oral presentation skills
• Experience in pharmaceutical project management is desirable
• In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio, SharePoint and other reporting/tracking tools