Senior Process Engineer, MSAT

oxfordbiom•Durham, NC

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 Senior Process Engineer, MSAT (Viral Vector Manufacturing) to join our team. In this role, you will be 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.

Requirements

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 in upstream / downstream operations including equipment knowledge and processes, including but not limited to disposable technologies, clarification holders and devices, chromatography skids, TFFs, formulation processes, final fill, etc.
Experience in late-stage process development
Experience driving process and product risk assessments using FMEA or similar methodologies.
Successful track record of providing deliverables in the areas of cGMP readiness and technology transfer

Responsibilities

Serves as project lead and/or principal investigator of projects to establish cGMP operations and manufacturing.
Leads and at times manage 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.
May support other tasks as determined by management.