Senior Director, CMC Technical Operations, siRNA Therapeutics

Key Goals and Accountabilities:

• Lead CMC strategy for one or more siRNA programs, aligning manufacturing plans with development timelines and corporate objectives to enable seamless clinical progression and long-term commercialization readiness
• Drive development, optimization, scale-up, and tech transfer of oligonucleotide drug substance processes—including solid-phase synthesis, deprotection, purification (e.g., HPLC, TFF), and GMP manufacturing—to ensure robust and reliable supply
• Advance drug product development, including formulation and lipid nanoparticle (LNP) encapsulation, delivering phase-appropriate control strategies, comparability plans, and risk assessments that support regulatory success
• Provide strong technical oversight of CDMOs, leading manufacturing campaigns, managing deviations and investigations, and ensuring quality and regulatory alignment across global partners
• Integrate innovative technologies—including AI-enabled data analysis and digital process tools—into CMC operations to accelerate development timelines, enhance decision-making, and conserve valuable resources

Required Qualifications:

• BS, MS, or PhD in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
• 12+ years experience in CMC development within biotechnology, with direct experience in siRNA, oligonucleotide, or other RNA-based therapeutics
• Demonstrated expertise in oligonucleotide drug substance manufacturing, including scale-up and GMP tech transfer
• Experience overseeing CDMO partnerships and external manufacturing activities in a clinical-stage setting
• Strong knowledge of global regulatory expectations for CMC documentation and phase-appropriate development strategies, with experience supporting IND and early clinical programs
• Excellent technical writing and communication skills, with the ability to influence cross-functional stakeholders
• Active user of large language models (LLMs) with a strong interest in evolving AI technologies and their application to CMC and technical operations

Preferred Qualifications:

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