Key Responsibilities:
- Lead CMC project management for small molecules and biologics across development, late-phase, commercialization, and commercial manufacturing.
- Partner with Product Strategy Leads to advance integrated product strategies with respect to CMC activities.
- Serve as subject matter expert across lifecycle stages; enable seamless transitions from early development through commercialization.
- Align CMC strategies/timelines with clinical, regulatory, and commercial objectives.
- Drive risk identification/mitigation and manufacturing & supply operational readiness.
- Lead, coach, and develop a team of project managers; oversee Director-level PMs for non-product initiatives.
- Support implementation/continuous improvement of Planisware and standardized planning tools; use templated tools/processes.
- Partner with Product Teams and Finance on budget planning/tracking.
- Integrate emerging AI and digital technologies into project management practices.
Basic Qualifications:
- BS/BA with 14+ years experience OR MS/MA or MBA with 12+ years OR PhD/PharmD with 12+ years.