💼 About This Role

You'll lead CMC strategy for siRNA programs from late discovery through commercialization, serving as the technical lead across internal teams and external partners. You'll drive robust, scalable manufacturing processes for oligonucleotide drug substance and drug product. This is a senior individual contributor role with broad cross-functional influence in a dynamic biotech environment.

🎯 What You'll Do

• Lead CMC strategy for siRNA programs aligning manufacturing plans with development timelines.
• Drive development, optimization, scale-up and tech transfer of oligonucleotide drug substance processes.
• Advance drug product development including formulation and lipid nanoparticle encapsulation.
• Provide technical oversight of CDMOs leading manufacturing campaigns and managing deviations.

📋 Requirements

• 12+ years experience in CMC development with direct experience in siRNA or oligonucleotide therapeutics.
• Demonstrated expertise in oligonucleotide drug substance manufacturing including scale-up and GMP tech transfer.
• Experience overseeing CDMO partnerships and external manufacturing in a clinical-stage setting.
• Strong knowledge of global regulatory expectations for CMC and phase-appropriate development strategies.

✨ Nice to Have

• Experience contributing to regulatory submissions (IND/CTA/BLA) including authoring CMC sections.
• Experience supporting nucleic acid drug product development including LNP-based delivery systems.
• Ability to operate as a senior individual contributor in a fast-paced, matrixed biotech environment.

🚩 Heads Up

• Role is individual contributor but with broad cross-functional influence, may have high expectations without direct reports.
• Requires active use of LLMs and evolving AI technologies, which may be niche or quickly outdated.