Responsibilities:
- Develop and maintain CMC project plans (Chemistry, Manufacturing, and Controls) for Product Presentation & Device Strategy Teams (PPDST) using standardized project management tools/processes; maintain PPDST rosters, create timeline swim lanes, and perform scenario planning.
- Lead PPDST team meetings (agenda/action items), drive deliverables/accountability, develop planning scenarios, identify/monitor/analyze business risks, and conduct root cause analyses with recommendations.
- Ensure teams have appropriate tools/reports/Asset Management Platform (AMP) data for resource estimates; support knowledge management communication (e.g., SharePoint/Teams).
- Identify and execute cross-functional process improvement initiatives; translate departmental goals into tasks, estimate/manage requirements, and prioritize work.
- Support peer Project Managers/PPDST Co-Chairs on monthly plan issues; provide change request data entry.
- Use advanced project management tools for metrics collection/analysis; develop guidelines/checklists.
- Serve as local expert for business procedures; provide training/presentations/guidance; mentor junior staff.
- Build/manage internal and external networks; influence senior leaders; define performance expectations; may manage Sr. Specialists and/or Program Managers.
Qualifications:
- BS in technical/scientific discipline + 10+ years pharma/biotech experience; or MS + 8+ years; or Doctorate + 4+ years (higher ed may substitute).
- Project management/process improvement accreditation highly preferred (e.g., PMP, LEAN Six Sigma).
- 4+ years project management experience with cross-functional team leadership.
- Strong leadership and communication; ability to influence/present/justify; negotiation/conflict management; cross-cultural/team-building and training experience.
- Knowledge of drug development process; cross-functional and global project leadership.
- Expertise in project management/business excellence tools (e.g., MS Office, MS Project, Qlikview, Spotfire).
- CMC experience required.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) for eligible employees; eligible for long-term incentive programs.