Manufacturing Specialist II — Gene Therapy Ops

Oxford Biomedica; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Career development

State-of-the-art labs

Collaborative culture

Job summary

Oxford Biomedica in Durham, NC is seeking a Specialist II for the Manufacturing team to troubleshoot process and equipment issues and develop process solutions. You will support technology transfers, client visits, and audits to advance our mission.

The role requires a BS in engineering or life sciences with 5+ years of relevant experience; strong quality investigation and deviation writing skills are essential. US work eligibility is required.

Qualifications

• BS in engineering or life sciences required; advanced degree desirable.
• 5+ years of relevant industry experience in manufacturing environments.
• Experience with quality investigations and deviation writing is required.

Responsibilities

• Provides technical support for the manufacture of gene therapy products and master cell bank; troubleshoots process and equipment issues and develops solutions.
• Authors and revises SOPs, training documents, and batch records (BPRs).
• Leads deviation investigations and CAPAs to prevent recurrence using RCA tools.
• Identifies and implements continuous improvement projects to improve safety, yield, reliability, and process robustness, employing Lean tools.
• Supports equipment qualification/re-qualification activities and change controls in manufacturing.
• Participates in tech transfer of new products into the facility.

Skills

Process troubleshooting

Quality investigations

Deviation writing

CAPA implementation

Root cause analysis

Lean tools

Education

BS in engineering or life sciences

Job description

Oxford Biomedica in Durham, NC is seeking a Specialist II for the Manufacturing team to troubleshoot process and equipment issues and develop process solutions. You will support technology transfers, client visits, and audits to advance our mission.

The role requires a BS in engineering or life sciences with 5+ years of relevant experience; strong quality investigation and deviation writing skills are essential. US work eligibility is required.