Job at a glance
Job Title: Associate Director, CMC Technical Development 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.
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 to enhance robustness, efficiency, and scalability of manufacturing processes.
Proactively identify, assess, and mitigate technical and operational risks across development and manufacturing programs. Provide PMO-style program leadership across development and manufacturing initiatives, ensuring effective governance, tracking, and reporting. Manage relationships with CDMOs and CMOs, including performance oversight and resolution of technical development and manufacturing issues.
Contribute to the development, review, and continuous improvement of quality systems, including deviations, investigations, CAPAs, and change control. Operate independently in a consulting-oriented environment, taking ownership of projects and delivering high-quality outcomes. Run and oversee the CMC function, serving as a key technical and strategic partner for tech transfer and manufacturing scale-up activities.
Essential Skills Bachelor's, Master's, or PhD in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related scientific discipline. 10+ years of experience in the pharmaceutical or biotechnology industry. Direct experience supporting oligonucleotide therapeutics, including PMOs, siRNA, ASOs, or related nucleic acid modalities. Strong CMC development experience in drug substance and/or drug product development.
Demonstrated experience with technology transfer activities from development to manufacturing environments. Proven experience managing external CDMO and CMO relationships for development and GMP manufacturing. Experience in manufacturing scale-up for oligonucleotide or related modalities. Strong understanding of GMP regulations and quality systems, including deviations, inve