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 regulatory and quality standards related to gene-editing therapeutics, with experience in IND submissions and other regulatory milestones.
• Strong project management skills, with the ability to drive high-impact projects to successful completion.
• Leadership and team management skills, capable of building and leading cross-functional teams in a collaborative environment.
• Effective communication and decision-making skills to influence across the organization.
• Familiarity with gene-editing technologies such as CRISPR/Cas, siRNA, and mRNA, with experience applying AI/ML techniques in process development and engineering.
• Experience working with CDMOs for tech transfer and manufacturing, ensuring seamless transition from lab-scale to commercial-scale production.
• Successful history of IND submissions or other regulatory achievements for LNP-based therapeutics.

California Pay Transparency Disclosure:

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.

Applicants/Employees have rights under various State and Federal Employment Laws, including without limitation:

• Family & Medical Leave Act
• Equal Employment Opportunity Commission
• Employee Polygraph Protection Act
• California Family Rights Act
• California Fair Employment and Housing Act

Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Metagenomi. Agencies and independent recruiters must be approved as a vendor by Metagenomi's Talent Acquisition team. To protect the interests of all parties, Metagenomi will not accept unsolicited resumes, profiles, or biographies. Any unsolicited resumes sent to Metagenomi will be considered referrals and the property of Metagenomi.

Metagenomi Applicant Privacy Notice

Purpose of Data Collection

At Metagenomi, we are committed to protecting the privacy of our job applicants. The personal information you provide during the application process is collected to evaluate your suitability for employment with Metagenomi. This notice outlines how we collect, use, store, and protect your personal data.

Types of Data Collected

We may collect and process the following types of personal information:

• Contact Information: Name, address, phone number, email address.
• Employment History: Previous employers, job titles, dates of employment.
• Education: Educational institutions attended, degrees earned.
• References: Names and contact information of your references.
• Other Relevant Information: Any additional information you choose to provide in your application or resume.

Data Usage

The personal information we collect is used for the following purposes:

• To process and evaluate your job application.
• To communicate with you about your application status.
• To conduct background checks and verify your information.
• To comply with legal and regulatory requirements.

Data Sharing

We may share your personal information with:

• Internal Departments: Relevant Metagenomi departments involved in the recruitment process.
• Third-Party Service Providers: Background check companies, recruitment agencies, and other service providers who assist us in the recruitment process. These providers are obligated to protect your information and use it only for the purposes specified by Metagenomi.
• Legal Authorities: As required by law or in response to legal processes.

Data Storage and Security

Your personal information is stored securely in our databases and systems. We use appropriate technical and organizational measures to protect your data against unauthorized access, loss, or misuse. Your data will be retained for as long as necessary to fulfill the purposes for which it was collected or as required by law.

Applicant Rights

You have the following rights regarding your personal information:

• Access: You can request access to the personal information we hold about you.
• Correction: You can request corrections to any inaccurate or incomplete information.
• Deletion: You can request the deletion of your personal information, subject to legal and regulatory obligations.
• Objection: You can object to the processing of your personal information in certain circumstances.

Metagenomi complies with applicable data protection laws, including the California Consumer Privacy Act (CCPA) and the General Data Protection Regulation (GDPR). We are committed to protecting your privacy and ensuring that your personal information is handled in accordance with the highest standards.

By submitting your application, you acknowledge that you have read and understood this Applicant Privacy Notice and consent to the processing of your personal data as described above.