Specialist, Manufacturing Manufacturing Specialist I, Drug Product
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, Drug Product 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.
- Strong understanding of cGMPs is desirable.
Nice To Haves
- Experience with Fill/Finish and APS activities, including drug product isolators, filling, and visual inspection is preferred.
- Prior experience in quality investigations and deviation writing in a manufacturing environment is preferred.
Responsibilities
- Provides technical support for the manufacture of gene therapy products. Supports troubleshooting process and equipment-related issues and develops sound engineering solutions to address identified problems. Supports on-the-floor manufacturing for drug product and drug substance 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. Learn and utilize Lean tools provided by the site.
- Acts as system owner to support filling equipment qualification / re-qualification activities.
- Write and implement change controls and change control impact assessments for the drug product manufacturing area.
- Participate in tech transfer of new products into the OXB Durham facility.
- Provides training and technical development for the manufacturing team.
- Responsible for coordinating activities to support manufacturing (i.e. material and BPR issuance) as needed.
- Ensures manufacturing goals are achieved through robust safety practices and quality compliance.
- Works closely with Manufacturing and Quality to continually improve all aspects of operations.
- Provides support to client and guest visits on site.
- Supports audits, both internal and external.
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
Mid Level
