Director, LNP Drug Product Process Development & Engineering Emeryville, Califor

Director, LNP Drug Product 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.

We are seeking an experienced and highly motivated Director of LNP Drug Product Process Development and Engineering to lead our lipid nanoparticle (LNP) production technology platform for gene-editing therapeutics. This individual will oversee the development, scale-up, and optimization of LNP-based delivery systems, ensuring efficient and reliable encapsulation of gene-editing components. The ideal candidate will have a strong background in nanoparticle formulations, process engineering, drug product fill/finish activities and a proven track record in driving innovative solutions within the gene-editing space. This individual will manage a cross-functional team of engineers and scientists, collaborating with analytical sciences, research and development, quality assurance, regulatory, and manufacturing teams to scale up production processes from pre-clinical research through clinical and commercial stages. This role requires a strong understanding of Quality by Design (QbD) approaches, drug product process engineering, and innovative formulation technologies to drive successful clinical and commercial applications. This position will be based at our Emeryville, California headquarters.

Key Responsibilities:

• Lead the design, scale up development, and optimization of LNP drug product formulation processes and dosage form development for gene-editing therapeutics.
• Develop and execute process development strategies with a QbD approach, ensuring alignment with regulatory requirements and company goals.
• Collaborate with cross-functional teams including analytical sciences, R&D, clinical, manufacturing, and regulatory to drive project milestones.
• Oversee the development, scale-up, and tech transfer of LNP-based processes from lab-scale to clinical and commercial production.
• Ensure successful GMP production of clinical trial LNP DP materials including dosage-form development.
• Design and implement innovative strategies to improve encapsulation efficiency, stability, and delivery of gene-editing payloads for both hepatic and non-hepatic targets.
• Collaborate with Analytical Sciences to establish robust analytical methods to characterize LNP formulations to ensure consistency and quality across batches and support stability evaluations.
• Contribute to IND/CTA and other regulatory filings as appropriate.
• Ensure that all LNP processes are compliant with regulatory standards (FDA, EMA, etc.) and Good Manufacturing Practices (GMP).
• Lead efforts to develop process validation strategies for clinical and commercial readiness.
• Build and mentor a high-performing process development and engineering team.
• Foster a collaborative and innovative culture that encourages technical excellence and continuous improvement.

What you’ll bring:

• PhD in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field with a focus on nanoparticle formulations or gene therapies, or a Master’s degree and extensive industry experience.
• 10+ years of experience in process development, tech transfer and manufacturing of LNPs or nanoparticle-based delivery systems, preferably in gene-editing, RNA therapeutics, or nucleic acid delivery.
• Proven experience in managing and scaling processes from early-stage development to clinical/commercial manufacturing.
• Strong knowledge of regulatory and quality standards related to gene-editing therapeutics.

Technical Skills:

• Expertise in LNP formulation, lipid chemistry, and nanoparticle characterization.
• Strong knowledge of QbD methodologies, including design of experiments (DOE), process analytical technology (PAT), and risk management frameworks.
• Proficiency in process engineering, particularly in scale-up, manufacturing, and tech transfer.
• Experience with analytical methods (e.g., DLS, HPLC, microscopy) for LNP characterization.

Leadership Skills:

• Strong project management and organizational skills, with experience leading cross-functional teams.
• Ability to communicate effectively and drive decision-making at all levels of the organization.

Preferred Qualifications:

• Experience with CRISPR/Cas, siRNA, mRNA, or similar gene-editing technologies.
• Experience working with CDMOs for tech transfer and manufacturing.
• A history of successful IND submissions or other regulatory milestones for LNP-based therapeutics.
• Experience with applying AI/ML techniques in process development and engineering is highly desirable.

This position is classified as exempt under the Federal Labor Standards Act. The anticipated base salary range for new hires is $230,000 to $255,000, depending on the role offered. In addition to base salary, you may be eligible to receive equity, cash bonuses, and a comprehensive benefits package covering medical, financial, and other services. Please note that the total compensation will be determined at the Company’s discretion and may vary based on several factors, including but not limited to location, skill level, relevant experience, and educational background.

What makes Metagenomi a unique place to work?

• We are passionate about developing technologies derived from microbial-rich ecosystems that have the power to enable therapeutic development and the potential to cure devastating diseases.
• We have cultivated an amazing culture that values teamwork, curiosity, scientific rigor, and fun. We have a strong commitment to work/life balance, host a weekly employee happy hour and events, provide catered lunches and endless snacks, and more!
• We offer competitive compensation, including a market-benchmarked salary, annual target bonus potential, equity, comprehensive benefits plan, 401(k) with company matching, retirement safe harbor plan, and other perks.

At Metagenomi, we know that our people drive our success. We are an equal opportunity employer and believe in and value diversity and inclusion. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. Metagenomi does not discriminate on the basis of race, color, religion, sexual orientation, gender, age, physical or mental disability, or any other status protected under federal, state, or local law.