Quality Control Senior Analyst (Micro)

Join Us in Changing Lives 

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. 

Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina, we have exciting new opportunities to join our growing team. 

We’re currently recruiting for a Quality Control Senior Analyst, Microbiology to join our Quality Control team. In this role, you will perform microbiological testing, environmental monitoring, data review and trending, and implementation of GMP operational systems—ensuring a compliant, efficient, and high-performing QC laboratory. You will play a key role in maintaining product quality and supporting the manufacture of life-changing therapies. 

Your responsibilities in this role would be: 

• Perform cGMP microbial testing including endotoxin, bioburden, and environmental monitoring. 

• Review and evaluate raw data from analytical methods and sample authorization at a peer or technical level. 

• Author, review, and/or approve SOPs, policies, and technical reports with general guidance. 

• Lead laboratory deviations and investigations (IA, OOS, AR), including assessments, authoring protocols/reports, and closure with minimal guidance. 

• Lead, author, perform, review, and/or approve equipment validations with minimal supervision. 

• Implement, lead, and/or support operational systems including equipment/instrument maintenance and calibration, alarm monitoring, sample handling/tracking, data integrity, cGMP documentation, LIMS, laboratory audits, and method training. 

• Execute phase-appropriate test method validation protocols as needed. 

• Participate in preparing information for regulatory filings and inspections. 

• Lead and support CAPA and continuous improvement initiatives. 

We are looking for: 

• Education: Minimum BS in Microbiology or related field. 

• Experience: 3+ years in a cGMP/GxP environment preferred. 

• Hands-on experience with environmental monitoring, facility qualification, bioburden, endotoxin, and other microbiological methods. 

• Demonstrated scientific leadership, strong initiative, and ability to work independently in a fast-paced environment. 

• Direct experience authoring, reviewing, and approving SOPs. 

• Excellent organizational, analytical, and communication skills, with a collaborative and proactive mindset. 

• A passion for addressing critical unmet medical needs and improving patient lives.