Quality Control Senior Analyst (Micro)

Location: Durham, NC, US

About the role

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.

Responsibilities

• 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.

Requirements

• Minimum BS in Microbiology or related field.
• 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.

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

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 process 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.

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