Manufacturing Senior Specialist
About The Position
OXB is recruiting a Senior Specialist to provide technical oversight and direct support to manufacturing operations at its viral vector manufacturing site in Durham, North Carolina. The role supports the manufacture of gene therapy products and master cell banks, with a focus on process improvement, troubleshooting, operational excellence, and quality compliance. The position also coordinates manufacturing schedules, supports technology transfers and new product introductions, and leads continuous improvement initiatives. It includes developing and mentoring manufacturing teams while promoting a strong culture of quality and compliance. Work authorization sponsorship is not offered; external applicants must be eligible to work in the United States.
Requirements
- B.S. in engineering or life sciences.
- At least 6 years of relevant industry experience.
- Strong understanding of cGMPs.
- At least 4 years of experience with quality investigations and deviation writing in a manufacturing environment.
- Manufacturing experience in upstream, downstream, or fill/finish operations.
Nice To Haves
- Advanced degree.
- Viral vector manufacturing experience.
- Experience scheduling and organizing production logistics.
- Experience with CMMS systems.
Responsibilities
- Lead technical support for manufacturing gene therapy products and master cell banks, including process improvement and troubleshooting complex manufacturing issues.
- Coordinate manufacturing schedules, capacity planning, and communication of priorities and progress across cross-functional teams.
- Lead deviation investigations and root cause analyses, implement CAPAs, and support timely closure of quality records.
- Support new product introductions through technology transfer, working with clients and internal stakeholders.
- Lead continuous improvement initiatives focused on safety, quality, process robustness, reliability, and manufacturing efficiency using Lean methodologies.
- Develop, coach, and mentor manufacturing teams through technical training, performance development, and sharing best practices.
Benefits
- Competitive total reward packages.
- Wellbeing programs supporting mental and physical health.
- Career development opportunities.
- Supportive, inclusive, and collaborative culture.
- State-of-the-art labs and manufacturing facilities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
