Job at a glance
Job Title: Associate Director, CMC Technical Development- 20 hours a week (Part-Time) Job Description The Associate Director, CMC Technical Development provides technical leadership and comprehensive program oversight for oligonucleotide-based therapeutic programs, including PMO and siRNA platforms. This role drives CMC execution across development, manufacturing, scale-up, and commercialization readiness, while coordinating and managing external CDMOs 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 and process development initiatives. Responsibilities Provide technical leadership for oligonucleotide-based therapeutic programs, with a focus on PMO and siRNA platforms. Lead CMC technical development activities across drug substance and drug product development lifecycles.
Coordinate and manage external CDMOs 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. 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 and reporting. Manage relationships with CDMOs and CMOs, including performance oversight and issue resolution related to technical development and manufacturing.
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. 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, investigations, CAPAs, and change control. Hands-on experience reviewing batch records and manufacturing documentation for GMP compliance. Demonstrated PMO or program leadership experience across development and manufacturing organizations.
Ability to operate independently and effectively in a consulting environment. Expertise in CMC technical development for oligonucleotides and related platforms. Experience with manufacturing oversight in GMP environments. Additional Skil