Director, Small Molecule Drug Product - Remote

Overview

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.

In Short

• Lead small molecule drug product development.
• Oversee CDMO activities including technology transfer and process optimization.
• Ensure compliance with cGMP requirements.
• Collaborate with CMC teams and other departments.
• Prepare and review documentation for drug product manufacturing.
• Manage multiple projects and provide on-site monitoring.
• Write development reports and prepare presentations.
• Contribute to regulatory filings for drug assets.
• Foster an inclusive and collaborative work environment.
• 15-20% travel required.

Requirements

• BS degree in pharmacy, chemical engineering, or pharmaceutics.
• 10+ years of experience in drug product development.
• Strong skills in technical documentation and report writing.
• Knowledge of cGMP regulations and ICH guidance.
• Experience with IND and NDA filings.
• Ability to work independently and manage projects.
• Hands-on experience with laboratory research and development.
• Proficiency in MS Office and statistical software.
• Experience in program management is a plus.

Benefits

• Comprehensive benefits package.
• Competitive compensation.
• Flexible work environment.
• Opportunities for professional development.
• Inclusive company culture.