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. 

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 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: 

Leadership & Strategy:

• 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.

Process Development & Engineering:

• 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.

Regulatory & Quality Compliance:

• 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.

Team Development & Management:

• 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

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.