Quality Control Analyst (Microbiology)

About Us

OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), adenovirus, and other viral vector types.

OXB’s world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise. OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion processes using process enhancers, and stable producer and packaging cell lines.

OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, Bedford MA, and Durham NC, US.

About the Role

Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina, we are recruiting for a Quality Control Analyst to join our Quality Control team. In this role, you will perform microbiological testing, environmental monitoring, data review and trending, and support the implementation of GMP operational systems to ensure a compliant Quality Control laboratory. You will collaborate closely with Manufacturing, Facilities, Quality Assurance, and other key functions as needed.

Responsibilities

• Perform cGMP microbiological testing, including endotoxin, bioburden, and environmental monitoring, among others.
• Review and evaluate raw data for accuracy and compliance, performing peer and technical reviews, as well as sample authorization.
• Author, review, and approve SOPs, policies, and technical reports in alignment with quality and regulatory standards.
• Lead laboratory deviations and investigations (IA, OOS, AR), including assessment, protocol/report authoring, and investigation closure with minimal guidance.
• Lead or support equipment validation activities, including authoring, execution, review, and approval.
• Implement and maintain operational systems such as equipment maintenance/calibration, alarm monitoring, sample handling/tracking, data integrity, cGMP documentation, LIMS management, laboratory audits, and method training.
• Execute phase-appropriate test method validation protocols as required.
• Contribute to regulatory filings and inspections, providing relevant data and documentation support.
• Drive continuous improvement initiatives, including CAPA development and implementation.

Requirements

• Minimum BS in Microbiology or other related field.
• 3+ years of experience in a cGMP/GxP environment is preferred.
• Hands-on experience with environmental monitoring, facility qualification, bioburden, endotoxin, and other microbiological methods.
• Direct experience in authoring and review/approval of SOPs.

Qualifications

• Demonstrate a strong initiative and scientific leadership.
• Superb organizational, analytical, and communications skills and a “do-what-it-takes” attitude.
• A passion for addressing the critical unmet medical needs of patients.
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

Benefits

• Competitive total reward packages.
• Wellbeing programs that support your mental and physical health.
• Career development opportunities to help you grow and thrive.
• Supportive, inclusive, and collaborative culture.
• State-of-the-art labs and manufacturing facilities.
• A company that lives its values: Responsible, Responsive, Resilient, Respect.

Nearest Major Market: Durham
Nearest Secondary Market: Raleigh