Role Overview

Leads all CMC and Technical Operations activities across drug substance and drug product development, from preclinical through clinical supply. Oversees scale?up, process chemistry, manufacturing, formulation, and supply chain in a fast?paced, entrepreneurial environment.

Key Responsibilities

• Direct drug substance and drug product development and manufacturing for preclinical and clinical programs.
• Manage external partners for process optimization and cGMP production of API and DP.
• Develop strategies and DOE approaches to ensure robust, scalable, cost?effective processes and formulations.
• Oversee technology transfer to internal or external manufacturing sites.
• Forecast API/DP needs and collaborate on program budgets.
• Lead formulation development for clinical studies.
• Manage supply chain and logistics for clinical materials.
• Ensure analytical methods, quality systems, and partner operations meet regulatory standards.
• Contribute to regulatory submissions and serve as CMC representative to global authorities.
• Review batch records, quality documentation, and prepare technical reports and presentations.

Required Skills and Experience

• Extensive experience managing U.S. and international CROs/CMOs for cGMP oligonucleotide API and DP manufacturing.
• Strong background supporting Phase 1-3 clinical programs.
• Deep knowledge of cGMP, IND/CTA/NDA submissions, and FDA/EMA regulations.
• 10+ years in pharmaceutical or biotech CMC environments.
• Experience in supply chain management for clinical programs.
• Advanced degree in a relevant scientific discipline.
• Proven ability to troubleshoot critical issues and execute technical and operational plans.
• Excellent communication and leadership skills, with experience guiding internal teams and external partners.
• Demonstrated self?awareness and collaborative leadership style.