Senior Process Engineer, MSAT

oxfordbiom•Durham, NC

3d•Onsite

About The Position

OXB is seeking a Senior Process Engineer, MSAT (Viral Vector Manufacturing) to join their team in Durham, North Carolina. This role is responsible for early and late-stage technology transfers, leading the assessment and transfer of new manufacturing processes to support clinical and commercial manufacturing. The ideal candidate will have a desire for personal and professional growth.

Requirements

Bachelor’s degree in Biochemistry, Chemical Engineering, or related field (advanced degree preferred)
8+ years of experience in pharmaceutical or biologics industry in process development or manufacturing operations
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.
External applicants must be eligible to work in the United States.

Nice To Haves

Advanced degree preferred

Responsibilities

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.