Compensation Overview

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 and provide oversight of cGMP manufacturing operations, ensuring 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.  

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