Full Job Description
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.
We9re 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:
37 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.
37 Authors and revises standard operating procedures (SOPs), training documents (OJTs), and batch records (BPRs).
37 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.
37 Identifies and implements continuous improvement projects to improve safety, yield, reliability, and/or process robustness. Learns and utilizes Lean tools provided by the site.
37 Acts as system owner to support equipment qualification / re-qualification activities.
37 Writes and implements change controls and change control impact assessments for the manufacturing area.
37 Participates in tech transfer of new products into the facility.
We are looking for:
37 B.S. in engineering or life sciences, with 5+ year9s relevant industry experience. Advanced degree is desirable.
37 Prior experience in quality investigations and deviation writing in a manufacturing environment is required.
37 Strong understanding of cGMPs is desirable.
37 Experience with producing and purifying biologics and/or commercial biologics manufacturing is strongly preferred.
37 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.
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.
