Director, CMC and Life Cycle Management (LCM) Lead

The Director of CMC and Life Cycle Management (LCM) Lead is responsible for creating and driving programs from development to commercial launch in collaboration with CMC leadership and cross-functional teams and for leading Life Cycle Management (LCM) activities post launch.

Requirements

• B.S. or B.E. in chemical engineering, bioengineering or related field
• 8+ years of Pharmaceutical/ Biotech industry experience in technical operations
• Strong technical understanding of CMC development from early to late stage, validation, and commercialization requirements
• Working knowledge of GMP regulations, PPQ expectations, and regulatory filing timelines (IND, BLA/NDA, supplements)
• 5+ years of Project Management experience and knowledge of project management methodologies, concepts and techniques
• Prior experience working in a fast-paced, entrepreneurial, development-stage company
• Prior experience managing third-party relationships
• Ability to manage complex, cross-functional projects with internal and external stakeholders
• Excellent written, communication and organizational skills
• Expertise using Project Management software to build timelines and manage resources, risks, and costs

Benefits

• 401k Matching
• Retirement Plan
• Health insurance
• Dental insurance
• Vision insurance
• Paid time off
• Flexible work hours
• Employee assistance program