Associate Director, Oligonucleotide Development

Role Summary:

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. 

This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.

Primary Responsibilities Include:

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.
• Innovate & Improve: Proactively identify and implement emerging technologies and "continuous improvement" initiatives to enhance product quality and manufacturing efficiency.
• Cross-Functional Liaison: Act as the primary CMC representative to internal teams, defining and defending compliant, phase-appropriate CMC strategies in a matrixed environment. Prepare technical source documents, publications, and oral presentations.
• Prepare and review relevant CMC and product related sections and documentation for global regulatory submission.
• Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports.

External Partner & Project Management

• CDMO Governance: Lead the selection, qualification, and strategic management of external CDMOs to ensure alignment with corporate goals and aggressive timelines.
• Technology Transfer: Spearhead the seamless transfer of processes and analytical assays to external partners, ensuring technical success and data integrity.
• Issue Resolution: Serve as the technical lead for resolving complex manufacturing or analytical challenges, driving timely and data-driven solutions.

Regulatory & Quality Compliance

• Regulatory Authoring: Lead the preparation and technical review of global regulatory filings (IND, IMPD, etc.), ensuring high-quality, submission-ready Module 3 content.
• GMP Oversight: Review and approve critical development and cGMP documentation, including Tech Transfer protocols, Master Batch Records (MBRs), and Campaign Summary Reports.
• Knowledge Dissemination: Oversee the creation of technical source documents, publications, and high-level presentations for internal stakeholders and external forums.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience. 
• 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.
• Strategic Problem Solving: Ability to navigate shifting priorities and evolving timelines using robust analytical and risk-mitigation capabilities.
• Collaborative Influence: Exceptional interpersonal and communication skills, with a proven ability to lead and influence cross-functional teams, contractors, and third-party vendors.
• Project Leadership: Strong project management skills, with the ability to independently drive complex CMC programs to completion within aggressive timelines.

 

 

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