Associate Director CMC Technical Development

About the role

The position is part-time at approximately 20 hours per week, with typical working hours in the morning aligned to Eastern Time to facilitate collaboration with development, quality, regulatory, and manufacturing partners. The Associate Director, CMC Technical Development provides technical leadership and comprehensive program oversight for oligonucleotide-based therapeutic programs, with a focus on PMO and siRNA platforms. This role drives CMC execution across drug substance and drug product development, manufacturing, scale-up, and commercialization readiness, while coordinating and managing external CDMOs and CMOs and ensuring robust technology transfer between internal teams and manufacturing partners. The position plays a key role in establishing high-quality, compliant processes and documentation to support early-phase GMP manufacturing, process development initiatives, and overall CMC strategy for oligonucleotide modalities. This is a Contract position based out of Waltham, MA. The role operates in a 100% remote work environment, with flexibility to work from an office if preferred. The work is conducted in a consulting-style setting that emphasizes autonomy, accountability, and close virtual collaboration across cross-functional teams, using standard digital communication and project management tools to support CMC and technical development activities.

Responsibilities

• Provide technical leadership for oligonucleotide-based therapeutic programs, with emphasis on PMO and siRNA platforms.
• Lead CMC technical development activities across the full drug substance and drug product development lifecycle.
• Coordinate and manage external CDMOs and CMOs supporting development, manufacturing, and scale-up activities.
• Drive CMC execution from early-phase development through commercialization readiness initiatives.
• Lead and support technology transfer activities between internal development teams and external manufacturing partners.
• Review manufacturing batch records and associated GMP documentation to ensure accuracy, completeness, and compliance.
• Oversee development timelines, risks, and deliverables, maintaining clear cross-functional communication and alignment.
• Ensure quality systems and manufacturing processes adhere to GMP regulations and industry best practices.
• Support early-phase GMP manufacturing activities and related process development initiatives for oligonucleotide therapeutics.
• Collaborate closely with analytical development, formulation development, product development, quality, regulatory, and manufacturing stakeholders to align CMC strategies and execution.
• Identify and implement process improvements