Senior Analyst, Quality Control

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 some new opportunities to join us.

We’re currently recruiting for a Senior Analyst I - QC Bioassay to join our Quality Control team. In this role, you will be establishing new commercial-level in-house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products, playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

• Perform cGMP analytical testing (ddPCR, qPCR, ELISA, and chromatography)
• Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization.
• Author, review, and/or approve SOPs/policies and technical reports with general guidance
• Lead laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required
• Lead, author, perform, review, and/or approve equipment validations with minimal guidance.
• Implement, lead and/or support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
• Execute phase-appropriate test method validation protocols as needed
• Participate in providing the necessary information for regulatory filings and inspections.
• Lead and support CAPA/Continuous Improvement Initiatives
• Act as manager designee for quality document review and approval

We are Looking For:

• BS with 5+ years of experience in a biotechnology discipline
• 5+ years of experience in a cGMP/GxP environment is preferred
• Hands on experience in ddPCR, quantitative PCR, and other bioanalytical methods such as ELISA and HPLC methods
• Demonstrate a strong initiative and scientific leadership
• Direct experience in authoring and review/approval of SOPs
• Superb organizational, analytical, and communications skills and "do what it takes" attitude
• A passion for addressing the critical unmet medical needs of patients
• Self-directed individual who can 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.

About Us:

OXB is a quality and innovation-led viral vector CDMO 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, we have more than 30 years of experience in viral vectors; the driving force behind the majority of 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) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

Why Join Us?

• 💸 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

We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.

Ready to Make a Difference?