Director, LNP Process Development & Engineering

Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world. 

Whether it's the biological diversity of our gene editing systems or the people that help discover them, Metagenomi celebrates the diversity of life. This is achieved through a compassionate culture that acknowledges the dimensions of our diversity.  We know that when people feel a sense of inclusion and belonging in the workplace, they have a safe space to bring creativity and innovation to everything they do. We are intentional about building and maintaining a culture where people are valued and respected, there is equity in opportunities, and our respective opinions and differences matter.

We are seeking an experienced and highly motivated Director of LNP Process Development and Engineering to lead the development and scale-up of our lipid nanoparticle (LNP) technology platform for gene-editing therapeutics. This role will oversee the entire lifecycle of LNP-based delivery systems, from pre-clinical development through clinical and commercial production, ensuring efficient and reliable encapsulation of gene-editing components. The ideal candidate will have a strong background in nanoparticle formulations, process engineering, and drug product fill/finish activities, with a proven track record in advancing innovative solutions within the gene-editing space. This position will be based at our Emeryville, California headquarters.

How You'll Contribute

• Leadership & Strategy:
• Lead the design, scale-up, and optimization of LNP formulations and drug product processes for gene-editing therapeutics.
• Develop and execute process development strategies with a Quality by Design (QbD) approach, ensuring alignment with regulatory requirements and company objectives.
• Collaborate cross-functionally with teams across R&D, analytical sciences, clinical, manufacturing, and regulatory to meet project milestones and business goals.
• Process Development & Engineering:
• Oversee the development, scale-up, and tech transfer of LNP processes from lab-scale to clinical and commercial production, ensuring GMP compliance.
• Design and implement strategies to enhance encapsulation efficiency, stability, and delivery of gene-editing payloads for both hepatic and non-hepatic targets.
• Partner with Analytical Sciences to establish robust methods for LNP characterization and ensure batch-to-batch consistency, supporting stability evaluations.
• Regulatory & Quality Compliance:
• Ensure all LNP processes comply with regulatory standards (FDA, EMA, etc.) and Good Manufacturing Practices (GMP).
• Lead process validation efforts for clinical and commercial readiness, contributing to regulatory filings such as IND/CTA.
• Team Leadership & Development:
• Build, mentor, and lead a high-performing process development and engineering team, fostering a culture focused on technical excellence, continuous improvement, and innovation.
• Promote collaboration and knowledge sharing across cross-functional teams to drive technical solutions and innovation.

What You Bring

• Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field with a focus on nanoparticle formulations or gene therapies.
• Candidates with a Master’s degree and extensive industry experience will also be considered.

• 10+ years of experience in LNP or nanoparticle-based delivery systems, particularly in gene-editing, RNA therapeutics, or nucleic acid delivery.
• Proven track record of scaling processes from early-stage development to clinical/commercial manufacturing, including tech transfer and collaboration with CDMOs.
• Strong background in drug product fill/finish activities and process engineering.

• Expertise in LNP formulation, lipid chemistry, and nanoparticle characterization, including analytical methods such as DLS, HPLC, and microscopy.
• Proficiency in QbD methodologies, including design of experiments (DOE), process analytical technology (PAT), and risk management frameworks.
• In-depth understanding of r