Senior Director, CMC Technical Operations, siRNA Therapeutics

Alector•South San Francisco, CA

8h•$240,000 - $270,000

About The Position

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 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 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.

Requirements

BS, MS, or PhD in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
Significant 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

Nice To Haves

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

Responsibilities

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 processesâincluding solid-phase synthesis, deprotection, purification (e.g., HPLC, TFF), and GMP manufacturingâto 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 technologiesâincluding AI-enabled data analysis and digital process toolsâinto CMC operations to accelerate development timelines, enhance decision-making, and conserve valuable resources!