Senior Director, CMC Management

Job Summary

Leading CMC activities for late-stage product development, the full-time Senior Director, CMC Management will work remotely from the West Coast, providing project leadership, managing budgets, and ensuring compliance with regulatory requirements.

Key responsibilities:

• Provide leadership in IND enabling and late-stage product development CMC activities
• Collaborate with CMC functional areas to ensure timely execution of projects and alignment with client goals
• Manage project scope, track progress, and address challenges while engaging with key stakeholders

Required qualifications:

• Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Science, or related field with 8+ years of relevant experience
• Strong knowledge of CMC strategy, risk management, and regulatory requirements
• Experience in multiple functional areas such as Project Management, Cell Line Development, or Manufacturing in the biologics industry
• Proven ability to write regulatory documents and manage multiple CMC projects simultaneously
• Demonstrated leadership skills and experience in managing CMC teams