Senior Director, CMC Technical Operations, siRNA Therapeutics

United States·South San FranciscoFull-time Exemptsenior

OtherDirector

3 views0 saves0 applied

Apply Now

Quick Summary

Overview

Technical Tools

data-analysistechnical-writing

Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. By harnessing advancements in genetics, immunology and neuroscience, we are pioneering the development of potential therapies to counteract the devastating progression of neurodegeneration. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history.

As the Senior Director, CMC Technical Operations, siRNA Therapeutics, you are a senior technical leader advancing siRNA programs from late discovery through clinical development and toward commercialization. You will serve as the CMC technical lead across internal teams and external partners, ensuring robust, scalable, and phase-appropriate manufacturing processes for siRNA drug substance and drug product.

This is an individual contributor role with broad cross-functional influence. You will report to the Vice President of Technical Operations and partner closely with Research, Process Development, Analytical Development, Regulatory, Quality, and CDMOs to deliver high-quality siRNA therapeutics in a dynamic biotech environment.

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

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

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