Associate Director, Manufacturing

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. This position will have an opportunity to 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. 

How you’ll contribute

• Manage the introduction of new products into manufacturing 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 executes 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 to process 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, proposes 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 mentors staff for growth and development
• Direct the authoring of manufacturing summary reports and leads 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

What you bring

• 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 and nucleic acid 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 an exempt position under the Federal Labor Standards Act.  The anticipated base salary range for this position will be $170,000 to $200,000.  You will also be eligible to receive equity, bonuses, and a full range of medical, financial, and other benefits depending on the position offered. 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. 

About Metagenomi

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. For more information, please visit https://metagenomi.co/.

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 cultivate