Specialist, Manufacturing

oxfordbiom•Durham, NC

About The Position

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. We’re currently recruiting for a Manufacturing Specialist I to join our Manufacturing team. In this role, you will be responsible for providing technical oversight and direct support to manufacturing operations, playing a key part in advancing our mission and making a real difference.

Requirements

B.S. in engineering or life sciences, with 3+ year’s relevant industry experience.
Prior experience in quality investigations and deviation writing in a manufacturing environment is required.
Strong understanding of cGMPs is desirable.
Experience with producing and purifying biologics and/or commercial biologics manufacturing is strongly preferred.
Manufacturing experience (upstream, downstream, Fill / Finish) is preferred.

Responsibilities

Provide technical support for the manufacture of gene therapy products and master cell banks, including on-the-floor manufacturing support as required. Troubleshoot process- and equipment-related issues and develop robust engineering solutions.
Author, review, and maintain standard operating procedures (SOPs), on-the-job training materials (OJTs), and batch production records (BPRs).
Lead and own deviation investigations to identify true root causes, applying standardized root cause analysis tools and methodologies, and implement effective corrective and preventative actions (CAPAs).
Identify, lead, and implement continuous improvement initiatives to enhance safety, yield, reliability, and process robustness, utilizing site Lean tools and methodologies.
Act as system owner to support equipment qualification and requalification activities.
Prepare, assess, and implement change controls and associated impact assessments for the manufacturing area.
Support the technical transfer of new products into the manufacturing facility
Coordinate manufacturing support activities, including material readiness and batch record issuance, as required.
Ensure manufacturing targets are achieved in full compliance with safety, quality, and regulatory standards.
Support client and visitor site tours and technical discussions as required.as well as support internal and external audits and inspections.