Seasoned Project Manager
MBA, PMP Project Management pharmaceutical professional with 10+ years of experience in Process Improvement, Validation & Qualification, 21 CFR part 11 Compliance, Process Engineering, Computer performance evaluation, Quality Assurance, Research and Development, and Manufacturing. Proven track record in delivering projects involving Process Improvement, Validation, and Qualification of Equipment and Facilities.
Relevant Therapeutic Areas
- Senior Project & Portfolio Manager
- Process Lead/Process Engineer
- Greater NY/NJ Area
- Open to remote, travel, and in-office
Skills & Accomplishments
- Certified in Drug Development, Project Management (PMP), and Culture-driven team building.
- Directed a supply chain project that resulted in savings of $1.1M in 4 months.
- Managed $20M FDA inspection readiness program and provided expert advice on a phased approach, timelines, and resource management.
- Managed pilot plant initiative budgeted at $30M and oversaw successful process validations of 2 OSD drugs.