Senior Manufacturing Specialist, Gene Therapy Ops

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

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.