Associate Director, Drug Product Development

Job Summary

To support drug product development initiatives, the full-time remote Associate Director, Drug Product Development will oversee outsourced manufacturing activities, serve as the technical contact for CDMO partners, and ensure alignment of drug product processes from development through commercial readiness.

Key Responsibilities

• Serve as the technical contact for CDMOs supporting drug product manufacturing and release activities
• Lead oversight of drug product development activities, including process development, tech transfer, scale-up, and validation
• Provide technical leadership for clinical and commercial drug product manufacturing campaigns, including review and approval of relevant documentation

Required Qualifications

• Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline
• 10+ years of relevant experience in pharmaceutical drug product development, manufacturing science, or related CMC functions
• Demonstrated experience supporting outsourced manufacturing models and managing CDMOs in a virtual environment
• Strong working knowledge of cGMP requirements and drug product process development principles
• Proven ability to technically oversee and influence external manufacturing partners