Associate Director, Oligonucleotide Development

Oligonucleotide Expertise: Proven track record in the process chemistry and development of PMO and ASO oligonucleotides, including deep technical knowledge of synthesis and purification.

CMC Lifecycle Mastery: Extensive experience defining and implementing CMC strategies from pre-IND/concept phases through clinical cGMP manufacturing.

External Management: Direct experience in the selection, qualification, and oversight of CDMOs, including managing technology transfers and cGMP manufacturing campaigns.

Regulatory Authority: Expert knowledge of FDA, EMA, and ICH guidelines with a successful track record of authoring and reviewing Module 3 sections for global regulatory submissions (IND, IMPD, etc.).

Analytical Depth: Technical proficiency in analytical development, including impurity control strategies and physicochemical characterization of payload and conjugated drug substances.

Collaborative Influence: Exceptional interpersonal and communication skills, with a proven ability to lead and influence cross-functional teams, contractors, and third-party vendors.

The Associate Director, Oligonucleotide Development will lead the chemical synthesis strategy for PMO and ASO payload molecules, managing execution both internally and across global CDMOs.

This role spans the full development lifecycle - from preclinical process and analytical development through GMP manufacture for IND-enabling studies.  The role will ensure the delivery of robust, scalable, and cost-effective manufacturing processes, serve as the primary technical lead for external CDMOs, driving aggressive timelines while delivering well-characterized products optimized for our proprietary bioconjugation platform.  As a core member of multiple CMC teams, the Associate Director of Oligonucleotide Development will steer the development of preclinical assets and define CMC strategies within a matrixed environment.

The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections.

Technical Leadership & Strategy

Drive Process Excellence: Lead the design, optimization, and execution of process development for PMO and ASO payload molecules, ensuring scalability for clinical and commercial supply.

Define Analytical Strategy: Set the vision for analytical development, focusing on robust impurity control strategies, raw material specifications, and comprehensive physicochemical characterization for both payloads and conjugated drug substances.