What are the responsibilities and job description for the Specialist I, Manufacturing position at OXB?
Location:
Durham, NC, US
Company: oxfordbiom
Join Us in Changing Lives
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.
Your responsibilities in this role would be:
About Us:
OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 30 years of experience in viral vectors; the driving force behind the majority of gene therapies.
OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
Why Join Us?
Ready to Make a Difference?
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh
Durham, NC, US
Company: oxfordbiom
Join Us in Changing Lives
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.
Your responsibilities in this role would be:
- 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.
- 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.
About Us:
OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 30 years of experience in viral vectors; the driving force behind the majority of gene therapies.
OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
Why Join Us?
- 💸 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
Ready to Make a Difference?
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh