Specialist I, Manufacturing
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.
Benefits
- Competitive total reward packages
- Wellbeing programs that support your mental and physical health
- Career development opportunities to help you grow and thrive
- Supportive, inclusive, and collaborative culture
- State-of-the-art labs and manufacturing facilities
- A company that lives its values: Responsible, Responsive, Resilient, Respect
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
501-1,000 employees
