What are the responsibilities and job description for the Quality Control Senior Analyst (Micro) position at OXB?
Location:
Durham, NC, US
Company: oxfordbiom
Quality Control Senior Analyst, Microbiology
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:
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?
Ready to Make a Difference?
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh
Durham, NC, US
Company: oxfordbiom
Quality Control Senior Analyst, Microbiology
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.
- 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.
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
Ready to Make a Difference?
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh