Director of Chemical Development - Remote

Overview

The Director, Chemical Development will lead CMC activities related to drug substance development and manufacturing, ensuring collaboration across teams and adherence to regulatory standards.

In Short

• Provide leadership in strategic planning and execution of CMC activities.
• Lead API operations across multiple CMC programs.
• Collaborate with CMOs for manufacturing initiatives.
• Develop strategies for robust supply chains.
• Ensure compliance with cGMPs and regulatory filings.
• Manage budget for CMC programs.
• Collaborate with Regulatory Science for CMC strategies.
• Review and approve manufacturing batch records and protocols.
• Manage oversight for manufacturing activities.

Requirements

• S. /M.S./Ph.D. in relevant Engineering or Science fields.
• 15+ years of experience in Technical Operations or pharmaceutical manufacturing.
• Experience with small and large molecule APIs.
• Strong understanding of project management systems.
• Excellent people management and communication skills.
• Ability to translate corporate vision into departmental goals.
• High-energy, learning-oriented candidate.
• Strong relationship-building skills.
• Proven ability to handle difficult issues and make decisions.

Benefits

• Comprehensive health, dental, and vision insurance.
• Generous paid time off including vacation and holidays.
• Bonus and stock equity opportunities.
• Work-life balance initiatives.