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We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.
Job Responsibility
Serving as the QC Microbiology SME for key strategic decisions related to microbiology, including contamination control, microbiological method strategy, environmental monitoring, utilities monitoring, facility readiness, and risk-based testing approaches
Leading all Microbiology operations, including bioburden, endotoxin, microbial ID, growth promotion, EM sampling, water testing, and trending
Troubleshooting microbiological assays, contamination events, and EM deviations, ensuring timely and compliant resolution
Providing daily in-lab mentorship to the QC team, fostering strong technique, aseptic practices, and microbiological best practices
Ensuring microbiology labs and adjacent QC spaces remain inspection-ready, including GMP housekeeping and equipment readiness
Reviewing micro data packages, protocols, reports, and testing documentation for accuracy and adherence to ALCOA++ principles
Collaborating with Analytical Development, Quality Assurance, Materials, and Manufacturing teammates to ensure smooth operational flow and timely release/testing
Requirements
Deep, hands-on Microbiology experience in a regulated (GMP) QC environment
experience mentoring or leading team members working within microbiology labs or cleanroom/controlled environments
10+ years of hands-on QC microbiology experience in a GMP setting
Bachelor’s degree in Microbiology or a related life sciences field
clear communication and collaboration
calm, structured decision-making under pressure
strong ownership, accountability, and solutions-focused mindset
organized, detail-oriented, committed to inspection readiness and data integrity
ability to thrive in an environment requiring in-lab leadership, cross-functional coordination, and prioritization of operational needs
What we offer
equity
annual bonus dependent on team and company performance