Senior Scientist, Regulatory CMC Biologics

Role Overview

• Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams
• Be accountable for the delivery of all regulatory milestones through product development and/or post-approval life cycle
• Ensure development of robust CMC regulatory strategies for assigned projects
• Manage execution of CMC documentation including IND/IMPD, original BLA/MAA, or Post approval/variations
• Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management

Requirements

• B.S. in a science, engineering, or a related field (advanced degree preferred)
• 5 years of Regulatory CMC related experience
• relevant experience including biological or vaccine drug substance/drug product development research, or manufacturing, testing and/or related field
• Business Processes
• CMC Documentation
• CMC Strategy
• Detail-Oriented
• Document Coordination
• Drug Product Development
• Interpersonal Relationships
• Pharmaceutical Products
• Regulatory CMC
• Regulatory Communications
• Regulatory Compliance
• Regulatory Interpretation
• Regulatory Project Management
• Regulatory Strategy Development
• Writing Technical Documents

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days