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Quality Control Senior Analyst (Micro) (Durham, NC, US) @ OXFORD BIOMEDICA (UK) LIMITED

Durham, NC, USOnsiteFull-time
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<div> <div> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong>Join Us in Changing Lives </strong></span></p> </div> <div> <p> </p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">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: <strong>Responsible, Responsive, Resilient, and Respectful.</strong> </span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">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. </span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">We’re currently recruiting for a <strong>Quality Control Senior Analyst,</strong> Microbiology to join our <strong>Quality Control team</strong>. 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. </span></p> </div> <div> <p> </p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong>Your responsibilities in this role would be: </strong></span></p> </div> <div> <p> </p> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Perform cGMP microbial testing including endotoxin, bioburden, and environmental monitoring. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Review and evaluate raw data from analytical methods and sample authorization at a peer or technical level. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Author, review, and/or approve SOPs, policies, and technical reports with general guidance. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Lead laboratory deviations and investigations (IA, OOS, AR), including assessments, authoring protocols/reports, and closure with minimal guidance. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Lead, author, perform, review, and/or approve equipment validations with minimal supervision. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">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. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Execute phase-appropriate test method validation protocols as needed. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Participate in preparing information for regulatory filings and inspections. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Lead and support CAPA and continuous improvement initiatives. </span></p> </li> </ul> </div> <div> <p> </p> </div> </div> <div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong>We are looking for: </strong></span></p> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Education: Minimum BS in Microbiology or related field. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Experience: 3+ years in a cGMP/GxP environment preferred. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Hands-on experience with environmental monitoring, facility qualification, bioburden, endotoxin, and other microbiological methods. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Demonstrated scientific leadership, strong initiative, and ability to work independently in a fast-paced environment. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Direct experience authoring, reviewing, and approving SOPs. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">Excellent organizational, analytical, and communication skills, with a collaborative and proactive mindset. </span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt">A passion for addressing critical unmet medical needs and improving patient lives. </span></p> </li> </ul> </div> <div> </div> </div> <div> <div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.</span><span> </span></span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> </span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span>About Us:</span><span> </span></strong></span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> </span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>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.</span><span> </span></span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>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.</span><span> </span></span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>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.</span><span> </span></span></p> </div> <div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>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.</span><span> </span></span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> </span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span>Why Join Us?</span><span> </span><span> </span></strong></span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> </span></p> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>💸</span><span> </span><span>Competitive total reward packages </span><span> </span></span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>🧘</span><span> </span><span>Wellbeing programs</span><span> </span><span>that support your mental and physical health </span><span> </span></span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>🚀</span><span> </span><span>Career development opportunities</span><span> </span><span>to help you grow and thrive </span><span> </span></span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>🤝</span><span> </span><span>Supportive, inclusive, and collaborative culture </span><span> </span></span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>🧪</span><span> </span><span>State-of-the-art labs and manufacturing facilities </span><span> </span></span></p> </li> </ul> </div> <div> <ul style="list-style-type:disc"> <li style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>🌍</span><span> A company that lives its values:</span><span> </span><strong><span>Responsible, Responsive, Resilient, Respect</span><span> </span><span> </span></strong></span></p> </li> </ul> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> </span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span>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. </span><span> </span></span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><span> </span><span> </span></span></p> </div> <div> <p><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span>Ready to Make a Difference?</span></strong></span></p> </div> </div> </div> </div>

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