Director of Drug Product

Job Summary

Providing technical and strategic leadership, the full-time Director of Drug Product will oversee small molecule drug product development and manufacturing processes remotely, ensuring robust strategies from early clinical development through commercialization.

Key responsibilities

• Lead CMC strategy and execution for small molecule programs, managing formulation and process development activities
• Provide technical oversight for technology transfers, process validation, and GMP manufacturing readiness activities
• Analyze formulation and manufacturing data to guide product and process decisions and ensure alignment with regulatory expectations

Required qualifications

• Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline with 10+ years of relevant experience
• Demonstrated experience in therapeutic product formulation and process development, including commercialization experience
• Strong technical knowledge of drug product manufacturing processes and regulatory requirements
• Experience managing CDMOs and external partners in a highly outsourced operating model
• Proven ability to lead investigations and implement risk-mitigation strategies in a fast-paced environment