Specialist II, Manufacturing

Oxford Biomedica • Durham, NC

5d

About The Position

OXB is recruiting a Specialist II to join its Manufacturing team at its commercial-scale viral vector facility in Durham, North Carolina. The role provides technical support for manufacturing gene therapy products and master cell banks, including troubleshooting process and equipment issues, developing engineering solutions, and supporting on-the-floor manufacturing as needed. The Specialist II also supports technology transfers, client visits, and audits.

The role authors and revises manufacturing procedures, training documents, and batch records; leads deviation investigations and implements corrective and preventative actions; and identifies continuous improvement projects to improve safety, yield, reliability, and process robustness. It also acts as a system owner for equipment qualification and re-qualification, writes and implements change controls and impact assessments, and participates in transferring new products into the facility.

Applicants must be eligible to work in the United States. The position does not offer work authorization sponsorship.

Requirements

• Bachelor of Science in engineering or life sciences.
• At least 5 years of relevant industry experience.
• Prior experience in quality investigations and deviation writing in a manufacturing environment.
• Eligible to work in the United States; work authorization sponsorship is not offered.

Nice To Haves

• An advanced degree.
• Strong understanding of current Good Manufacturing Practices (cGMPs).
• Experience producing and purifying biologics and/or in commercial biologics manufacturing.
• Manufacturing experience in upstream, downstream, or fill/finish operations.

Responsibilities

• Provide technical support for the manufacture of gene therapy products and master cell banks.
• Troubleshoot process and equipment-related issues, develop engineering solutions, and support on-the-floor manufacturing as needed.
• Author and revise standard operating procedures, on-the-job training documents, and batch production records.
• Lead deviation investigations to identify root causes and implement corrective and preventative actions.
• Use standardized root cause analysis tools and methodologies.
• Identify and implement continuous improvement projects to improve safety, yield, reliability, and process robustness, using site-provided Lean tools.
• Act as system owner for equipment qualification and re-qualification activities.
• Write and implement change controls and change control impact assessments for the manufacturing area.
• Participate in technology transfer of new products into the facility.
• Support client visits and audits.

Benefits

• Competitive total reward packages.
• Wellbeing programs supporting mental and physical health.
• Career development opportunities.
• Supportive, inclusive, and collaborative culture.
• State-of-the-art laboratories and manufacturing facilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level