Associate Director, Oligonucleotide Development (Biotech)

Location: Waltham, MA, United States; onsite presence required 4–5 days per week with no remote option

Salary: $159,000–$195,000 USD base pay annually

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to address genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead process development, optimization, and execution for PMO and ASO payload molecules from preclinical development through clinical and commercial supply.
• Define analytical development strategies covering impurity control, raw material specifications, and physicochemical characterization of payloads and conjugated drug substances.
• Manage CDMO selection, qualification, governance, technology transfers, analytical assay transfers, and cGMP manufacturing campaigns.
• Serve as the technical lead for complex manufacturing and analytical issue resolution, using data-driven and risk-based approaches.
• Represent CMC within matrixed cross-functional teams and define phase-appropriate development strategies.
• Prepare and review technical documents, presentations, publications, and regulatory submission materials.

Requirements

• PhD or equivalent experience in a scientific discipline with 8+ years of related experience.
• Proven expertise in process chemistry and development of PMO and ASO oligonucleotides, including synthesis and purification.
• Extensive CMC experience from pre-IND or concept phases through clinical cGMP manufacturing.
• Experience selecting, qualifying, and overseeing CDMOs, including technology transfers and manufacturing campaigns.
• Expert knowledge of FDA, EMA, and ICH guidelines, with experience authoring and reviewing Module 3 sections for IND, IMPD, and other global submissions.
• Strong analytical development, project leadership, problem-solving, communication, and cross-functional influencing skills.

Culture & Benefits

• Work in a matrixed, cross-functional environment spanning internal teams, contractors, vendors, and global CDMO partners.
• Focus on continuous improvement, product quality, manufacturing efficiency, and aggressive development timelines.
• Participate in programs addressing genetically driven neuromuscular diseases and CNS and muscle-targeted therapeutics.
• Employment includes a stated annual base-pay range of $159,000–$195,000 USD.