Associate Director, QC Microbiology

We are seeking an experienced and motivated Associated Director, QC Microbiology to support Metagenomi's new and growing Analytical Sciences team within the Technical Operation group. This position will play a crucial role in Analytical Sciences, including managing QC microbiology team in day to day operations (microbiological sampling and testing), environmental and utility monitoring programs, material and lot release testing and support of aseptic manufacturing. The ideal candidate would have experience in setting up a new microbiology laboratory and collaborating with contract testing laboratories for method transfers and material testing. This role supports both the Manufacturing and Process Sciences/Development teams. This position is a combination of office based and laboratory based, and includes data analysis and experimental design, as well as network support to aseptic sites, supporting all drug modalities at Metagenomi.

About the Role

By the end of your first year, you will have a chance to demonstrate your ability to:

• Build and oversee the Quality Control Microbiology laboratory with a focus on facility utilities, environmental classification and control design, microbiology equipment and facility qualification/control
• Oversee execution of routine microbial testing (inhouse and outsourced), environmental and utility monitoring and raw material/growth promotion testing, aseptic gowning and training program, media fills, depyrogenation, isolator cleaning/decontamination qualifications
• Manage microbiology test method development, transfer, qualification and validation for in-process materials, lot release and stability, as needed, to support the Process Development and Manufacturing teams
• Support QC and manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on microbiology related topics
• Organize and direct cross functional relationships with Facilities, Process Sciences and Engineering, Quality Assurance, Program Management, Supply Chain and Cell Therapy group and Research and Development team
• Manage microbiology laboratory staff, set goals and expectations, and maintain efficient utilization of resources
• Ensures that all work is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs)
• Provide microbial control assessments and continuous improvement opportunities
• Participate in regulatory/internal/customer inspections/audit and draft response
• Responsible for laboratory investigations, deviations, OOS/OOT, CAPAs and Change Controls related to microbiology
• Presents analytical data reports clearly and concisely to senior management, including QC microbiology performance metrics and trends.
• Assist in the preparation of dossiers and data packages for interactions between Metagenomi and regulatory agencies
• Interact with inspectors/auditors as Microbiology SME and participate in internal, corporate and QP inspections
• Keep current on Environment, Health & Safety policies, ensure safe environmental and working conditions in the Microbiology lab

About You

• Requires MSc/PhD degree in Microbiology or other closely related life sciences discipline, with at least 8+ (for PhD) or 18+ years (for MSc) of relevant experience along with previous supervisory roles in a GMP QC Microbiology laboratory in an aseptic processing facility
• Strong knowledge of environmental and utility monitoring requirements and tests (viable and non-viable), Aseptic Process Validation (APV), USP/EP Microbiological methods and microbial identification (including rapid microbiology methods)
• Experience with pharmaceutical microbiology including gowning procedures, aseptic technique and contamination control within a clean room environment is desirable
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) for pharmaceutical and biopharmaceutical drugs, including specific review or preparation of INDs, BLAs, or supplements
• In depth knowledge of current regulatory requirements in support of cGMP manufacturing operations
• Experience with electronic systems such as LIMS, Trackwise, Veeva, etc., is an advantage
• Flexible to meet changing demands to support manufacturing activities
• Ability to communicate at all levels and across various functions
• Handle issues appropriately and with a sense of urgency
• Ability to problem solve and identify root cause
• Completes tasks where judgment is required in resolving problems and recommendations
• Frequent use & general knowledge of industry practices, techniques and standards
• Strong interpersonal and communications skills; written and oral
• Able to quickly learn and adapt to new software tools (ex: Google Suite, Slack, etc.)
• Highly collaborative, team-oriented, and considerate of the needs of others
• Thrives in a fast-moving, results-oriented startup environment with urgent deadlines
• Independent and self-sufficient, but knows when to ask questions or seek support
• Self-motivated, passionate about your work, and eager to continuously learn more

About the Company

At Metagenomi, we are accelerating innovation in cell and gene therapy with a wave of proprietary CRISPR-based 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 therapeutic tools that can be leveraged by partners and fuel our own pipeline of potentially curative medicines. Our goal is to revolutionize gene editing and unlock its power for the benefit of patients around the world.

• 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
• Metagenomi offers competitive salary, annual target bonus, equity in an early-stage startup, and a comprehensive benefits plan, including 401(k) matching, a retirement safe harbor plan, and other perks

At Metagenomi, we know that our people drive our success. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We are an equal opportunity employer and believe in and value diversity and inclusion. All employment is decided on the basis of qualifications, merit, and business need.

If you need assistance or accommodation due to a disability, you may contact us at hr@metagenomi.co and we would be happy to help.