Manufacturing Senior Specialist

OXB; Durham (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive total rewards

Wellbeing programs

Career development opportunities

State-of-the-art labs

Job summary

OXB in Durham, NC is seeking a senior manufacturing professional to lead technical support for gene therapy product manufacturing and master cell bank activities. You will own schedules, drive CAPA and investigations, and mentor teams to sustain quality and efficiency.

The role emphasizes cGMP mastery, quality investigations, and cross-functional collaboration, with preferred viral vector experience. This is a hands-on leadership position in a fast-paced biopharma environment.

Qualifications

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

Responsibilities

• Lead technical support activities for the manufacture of gene therapy products and master cell banks; drive process improvements, troubleshoot manufacturing issues, and ensure operational excellence.
• Own and coordinate manufacturing schedules; ensure efficient capacity planning and communicate priorities across cross-functional teams.
• Lead deviation investigations, root cause analyses, and CAPA implementation to drive compliance and continuous improvement.
• Support introduction of new products through technology transfer with clients and internal stakeholders.

Skills

cGMPs understanding

Quality investigations

Deviation writing

Production scheduling

Lean methodologies

Education

Bachelor's degree in engineering or life sciences

Tools

CMMS

Job description

Join Us in Changing Lives

At

Location: Durham, NC, US

Company: oxfordbiom

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.

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?

• 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?

The closing date for applications is 19th November 2026

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.

Nearest Major Market:

Durham

Nearest Secondary Market:

Raleigh