Senior Process Development Engineer Jobs in Durham, NC

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AtOXB, 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 Senior Process Engineer, MSAT (Viral Vector Manufacturing) to join our team. In this role, you willbe responsible for both early and late-stage technology transfers. The individual will have the desire to grow in both personal and professional areas of competence. The Sr. Process Engineer is responsible for leading the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing.

Your responsibilities in this role would be:

• Serves as project lead and/or principal investigator of projects to establish cGMP operations and manufacturing.
• Responsible for departmental deliverables and metrics to ensure compliance with departmental procedures and practices.
• Leads the introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of biological drug substances and products.
• Leads the information transfer and gap assessment of new processes and method transfers.
• Drafts and provides guidance for the preparation of unit operation technology transfer protocols.
• Provides guidance and leads facility fit assessments of manufacturing processes in production suites.
• Ensures compliance with the quality document management system for process changes.
• Provides guidance in the documentation of events and deviations during cGMP manufacturing production.
• Provides guidance for process equipment on-boarding and raw material/consumable enrollment.
• Provides mentorship and training to junior engineers on best practices and supports their development of cross-functional expertise where feasible.
• May support other tasks as determined by management.

We are Looking For:

• Bachelor’s degree in Biochemistry, Chemical Engineering, or related field (advanced degree preferred)
• Requires 8+ years of experience in pharmaceutical or biologics industry in process development or manufacturing operations
• Requires 8+ years of experience in cGMP manufacturing readiness and technology transfer
• Experience in monoclonal antibody production and purification process development
• Technical expertise upstream / downstream operations (both are preferable) including equipment knowledge and processes. Equipment includes single-use technologies, 50 – 500 L bioreactors, clarification holders and devices, chromatography skids, TFF systems, and final fill systems. Processes include cell expansion, transfection, depth filtration, chromatography, TFF, formulation, and DP filling.
• Experience in both clinical and late-stage site-to-site process transfer into a GMP environment.
• Experience driving process and product risk assessments using FMEA or similar methodologies.
• Successful track record of meeting business milestones and deliverables in the areas of cGMP readiness and technology transfer.

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

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.

• 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.