Senior Viral Vector Manufacturing 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

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.