Associate Director, Manufacturing

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 hiring an Associate Director,  Manufacturing Operations to lead and manage the Manufacturing team at Metagenomi. Reporting to the Senior Director, Process Engineering and Manufacturing, this position will direct the manufacturing operations at our GMP Manufacturing Facility. In this position, you can make a lasting impact as you partner with cross-functional teams to meet our manufacturing needs and advance our gene editing system development pipeline. This position will be on-site and based in Emeryville, California.  What you’ll do Manage introducing new products into manufacturing in a GMP in a manner compliant with cGMP Provide oversight of the cGMP manufacturing operations and ensure the production and resource scheduling is executed against the operational plan Prepare annual manufacturing operational budget and execute operations against the budget  Partner with QA to address audit reports, develop specifications, investigate deviations, and implementation of CAPAs Contribute to the development and approval of batch records, phase-appropriate control strategies, out-of-specification, and out-of-trend investigations  Assess the impact of change control on processes and qualified systems to ensure compliance  Ensure cGMP regulations/requirements for facilities and utilities for manufacturing are met, including participation in facility audits Assess gaps, propose solutions, and ensure timely execution of strategies to minimize risks. Establish and maintain cross-functional relationships with manufacturing, process engineering, and quality operations for efficient operations Communicate strategies and provide status updates to the broader CMC team Represent manufacturing team and mentor staff for growth and development Direct the authoring of manufacturing summary reports, lead process monitoring, and continuous improvement of manufacturing operations, as needed. Implement project management methodologies to streamline manufacturing operations Author sections of the CMC modules in support of regulatory submissions. Must haves Undergraduate (advanced degree preferred)  in Biochemical Engineering, Biochemistry, Biotechnology, or a closely related field At least ten years of GMP manufacturing experience, with at least five years of experience managing and leading teams Leadership and recent experience with plasmid, nucleic acid, and nanoparticle delivery manufacturing Demonstrated experience leading, managing, and mentoring manufacturing teams Demonstrated ability to develop focused strategies and translatable actions, including identification and prioritization Excellent oral and written communication skills Extremely organized and able to efficiently manage your time and workflow, including skillfully prioritizing both long-term projects and day-to-day responsibilities A highly collaborative and team-oriented approach to leadership, a high level of self-awareness, and a passion for making a  meaningful contribution to cell or gene therapy through your work. California Pay Transparency Disclosure: This position is classified as exempt under the Federal Labor Standards Act.  This position's anticipated base salary range will be $170,000 to $210,000.  Depending on the position offered, you will also be eligible to receive equity, bonuses, and a full range of medical, financial, and other benefits. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.   #LI-NG1   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 disease. 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, pre-IPO equity, and a comprehensive benefits plan, including 401(k) with company matching, a 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.