Specialist II, Manufacturing

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

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 Specialist II to join our Manufacturing team. In this role, you will troubleshoot process and equipment-related issues and develop process solutions to address identified problems. Directly supports technology transfers, client visits, and audits, playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be to:

• Provides technical support for the manufacture of gene therapy products and master cell bank. Supports troubleshooting process and equipment-related issues and develops sound engineering solutions to address identified problems. Supports on-the-floor manufacturing as needed.
• Authors and revises standard operating procedures (SOPs), training documents (OJTs), and batch records (BPRs).
• Owns and leads deviation investigations to identify the true root cause and implements appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Employs standardized root cause analysis, investigational tools, and methodologies.
• Identifies and implements continuous improvement projects to improve safety, yield, reliability, and/or process robustness. Learns and utilizes Lean tools provided by the site.
• Acts as system owner to support equipment qualification / re-qualification activities.
• Writes and implements change controls and change control impact assessments for the manufacturing area.
• Participates in tech transfer of new products into the facility.

We are looking for:

• B.S. in engineering or life sciences, with 5+ year’s relevant industry experience. Advanced degree is desirable.
• 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.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

About Us:

OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy 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, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and 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), adenovirus and other viral vector types. OXB’s world‑class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality‑assurance systems, analytical methods and depth of regulatory expertise.

OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines.

OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, Bedford MA, and Durham NC, US.

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

We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.

Ready to Make a Difference?

The closing date for applications is 12th November 2026

Please note:

Our vacancies are typically advertised for a minimum of 10 working days. Once a vacancy closes, it may take a few days for us to provide an update while our Talent Acquisition team and Hiring managers review all applications.

Every application is reviewed manually by our recruitment team and hiring managers. We do not use AI to screen CVs or make shortlisting decisions.