Manufacturing Senior Specialist

Oxford Biomedica; Durham (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Wellbeing programs

Career development opportunities

Supportive, inclusive culture

State-of-the-art labs and facilities

Values-driven workplace

Job summary

Oxford Biomedica in Durham, NC is seeking a Senior Specialist to provide technical oversight for viral vector manufacturing. You will lead manufacturing schedules, investigations, and CAPA programs while guiding cross-functional teams to ensure quality and regulatory compliance.

The role emphasizes process improvements, technology transfer support, and mentoring manufacturing staff to uphold a culture of quality and continuous improvement.

Qualifications

• B.S. in engineering or life sciences; 6+ years relevant experience; advanced degree desirable.
• Strong understanding of cGMPs.
• 4+ years' experience of quality investigations and deviation writing in a manufacturing environment.
• Manufacturing experience (upstream, downstream, or fill/finish); viral vector experience preferred.
• Experience scheduling and organizing production logistics; CMMS experience is a plus.

Responsibilities

• Lead technical support activities for the manufacture of gene therapy products and master cell banks, driving process improvements, troubleshooting complex manufacturing issues, and ensuring operational excellence.
• Own and coordinate manufacturing schedules, ensuring efficient capacity planning and clear communication of priorities and progress across cross-functional teams.
• Lead deviation investigations, root cause analyses, and CAPA implementation to drive compliance, continuous improvement, and the timely closure of quality records.
• Support the introduction of new products through technology transfer activities, working closely with clients and internal stakeholders to ensure successful implementation.
• Champion continuous improvement initiatives focused on safety, quality, process robustness, reliability, and manufacturing efficiency using Lean methodologies.
• Develop, coach, and mentor manufacturing teams through technical training, performance development, and best practice sharing while maintaining a strong culture of quality and compliance.

Skills

Scheduling

Quality investigations

Root cause analysis

CAPA

Education

B.S. in engineering or life sciences

Advanced degree desirable

Tools

CMMS

Job description

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AtOXB, 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 aSenior Specialist, to join our Manufacturing team. In this role, you will be responsible for providing technical oversight and direct support to manufacturing operations at the OXB Durham viral vector manufacturing site, playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be to:

• Lead technical support activities for the manufacture of gene therapy products and master cell banks, driving process improvements, troubleshooting complex manufacturing issues, and ensuring operational excellence.
• Own and coordinate manufacturing schedules, ensuring efficient capacity planning and clear communication of priorities and progress across cross-functional teams.
• Lead deviation investigations, root cause analyses, and CAPA implementation to drive compliance, continuous improvement, and the timely closure of quality records.
• Support the introduction of new products through technology transfer activities, working closely with clients and internal stakeholders to ensure successful implementation.
• Champion continuous improvement initiatives focused on safety, quality, process robustness, reliability, and manufacturing efficiency using Lean methodologies.
• Develop, coach, and mentor manufacturing teams through technical training, performance development, and best practice sharing while maintaining a strong culture of quality and compliance.

We are looking for:

• B.S. in engineering or life sciences, with 6+ year’s relevant industry experience. Advanced degree is desirable.
• Strong understanding of cGMPs is required.
• 4+ years' experience of quality investigations and deviation writing in a manufacturing environment is required.
• Manufacturing experience (upstream, downstream, or fill/finish) is required. Viral vector manufacturing experience is preferred.
• Experience scheduling and organizing production logistics is a plus.
• Experience with CMMS systems is preferred.

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.

Why Join Us?

• 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?

The closing date for applications is 19th November 2026

Please note:

Our vacancies are typically advertised for a minimum of 10 working days. Once a vacancy closes, it may take a few days for us to provide an update while our Talent Acquisition team and Hiring managers review all applications.

Every application is reviewed manually by our recruitment team and hiring managers. We do not use AI to screen CVs or make shortlisting decisions.