The Role
As Senior Director of CMC Technical Operations, you'll lead siRNA program development, ensure robust manufacturing processes, and oversee partnerships, driving compliance and quality in a biotech environment.
Summary Generated by Built In
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.
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
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At Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together.
Among the things you'll discover at Alector from your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us!
We believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
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Top Skills
Ai-Enabled Data Analysis
Gmp
Hplc
Lnp
Oligonucleotide
Sirna
Tff
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The Company
What We Do
We have always walked our own path, at Alector. That’s what led us to the bold thinking and fresh, new approach of empowering the body’s immune system to fight disease. Join us in our mission to eliminate neurodegeneration and cancer through immuno-neurology and immuno-oncology. We are developing a broad portfolio of programs, currently in various stages of clinical trials. Alector is based in South San Francisco, CA. We were founded in 2013 by thought leaders in biotechnology, neuroscience, and antibody drug discovery.
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