Senior Quality Control Microbiology Manager

Our Opportunity...

We’re looking for a Sr. QC Microbiology Manager, with a strong background in microbiology quality control activities to provide technical and operational leadership for cell and gene therapy products. This role supports contamination control strategy and oversees outsourced microbiology testing programs, environmental monitoring, and GMP microbiology compliance activities across external manufacturing networks. 

As a key contributor within Technical Operations, you’ll serve as the microbiology subject matter expert (SME) within the Quality Control organization and partner closely with Manufacturing, Quality Assurance, Analytical Development, MSAT, Regulatory Affairs, and external CDMOs to ensure compliant and phase-appropriate microbiological control strategies to advance the development of our first clinical stage autologous cell therapy program targeting solid tumors. 

This role is ideal for an experienced professional who thrives in a fast-paced biotech environment working with distributed teams, and has successfully managed outsourced GMP testing programs. As a member of our Quality organization, you’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.  

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. 

This is a hybrid position based out of our Bedford, MA location; remote candidates with uniquely relevant experience may be considered. 

You Will...

• Oversee outsourced microbiology testing at CDMOs and contract labs. 
  • Review, trend, and interpret microbiological data (sterility, endotoxin, mycoplasma, and environmental monitoring data). 
  • Ensure microbiology activities comply with GMP, regulatory, and internal quality requirements. 
  • Serve as microbiology SME during manufacturing campaigns, and support batch disposition. 
  • Support microbiology method qualification, validation, and transfer activities; review related protocols and reports for microbiological methods. 
  • Provide technical oversight for in-vitro safety testing of viral vector and cell banks, and rapid microbiological methods where applicable. 
  • Assess method suitability for cell and gene therapy matrices and products. 
• Support development and maintenance of contamination control strategies for cell therapy and viral vector manufacturing. 
  • Partner with Manufacturing and QA to assess contamination risks associated with aseptic processing; closed/semi-closed systems; viral vector and cell therapy manufacturing. 
  • Evaluate EM trends and recommend corrective and preventive actions. 
• Support microbiology-related investigations including OOS, OOT, deviations, contamination events, EM excursions, including root cause analysis using risk-based approaches. 
  • Develop scientifically sound CAPAs and effectiveness checks. 
  • Serve as primary QC microbiology contact for external testing laboratories and manufacturing partners. 
  • Participate in vendor qualification, technical meetings, quality reviews, audit readiness, and audit support. 
  • Ensure testing laboratories maintain phase-appropriate GMP compliance 
• Support regulatory submissions and responses related to microbiological control strategies. 
  • Participate in health authority inspections, client audits, and inspection readiness activities. 
  • Author and/or review microbiology sections of regulatory documents (e.g., INDs, BLAs, comparability packages, briefing documents). 
• Author and/or review QC documentation including SOPs, protocols, technical reports, risk assessments, specifications, and trending reports. 
• Support implementation and continuous improvement of QC systems and processes. 

You Bring...

Core Qualifications

• BS or MS Degree in Microbiology, Biology or Biochemistry with 8+ years of experience. 
• 5+ years of GMP microbiology experience in biotech/pharma, including support of cell therapy, viral vector, and/or biologics manufacturing 
• Successful experience managing outsourced GMP testing programs (CDMOs/contract labs) 
• Expertise in microbial testing and monitoring (e.g., sterility, endotoxin, mycoplasma, bioburden, and environmental monitoring). 
• Working knowledge of USP microbiology chapters and Annex 1 expectations; familiarity with contamination control strategies. 
• Experience supporting microbiology method qualification, validation, and transfer; microbiology investigations (deviations, OOS/OOT, contamination events, EM excursions); root cause analysis; and CAPAs. 
• Strong technical writing skills (SOPs, protocols, reports, specifications, risk assessments, trending). 
• Ability to operate effectively in a fast-paced, virtual/outsourced biotech environment; strong cross-functional collaboration. 
• Excellent planning, coordination, and time management skills   
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.   
• Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization   
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes 
• Self-motivated, with a proven ability to meet objectives, timelines, and high standards; managing multiple responsibilities in parallel.   
• Flexible - adapts to change in a fast paced, rapidly developing environment  
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner  
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency.