Engineer - Drug Substance Technology & Engineering
Core
Provide downstream purification process engineering support for clinical and commercial biologics drug substance products, including technology transfer, process validation, and manufacturing operations.
Role type
Process Engineer (Biologics Drug Substance)
Builds
Clinical and commercial biologics drug substance products
Domain
Biopharmaceutical manufacturing / Biochemical engineering
Required skills
Downstream purification, process scale-up, chromatography, viral inactivation, viral filtration, ultrafiltration, diafiltration, aseptic processing, cGMP manufacturing, process validation, statistical analysis, design of experiments, troubleshooting, equipment operation
Preferred skills
Chemical/Biochemical Engineering degree, 3+ years in process engineering for biologics, hands-on pilot/clinical/commercial purification experience, mammalian cell culture harvest and clarification, process deviation impact analysis
Technologies
Chromatography, ultrafiltration, normal flow filtration, virus inactivation, virus filtration, cGMP manufacturing systems
Responsibilities
Transfer purification processes from lab to manufacturing and between sites, provide on-the-floor technical support for scale-up and operations, perform routine and nonroutine process monitoring and troubleshooting, trend process data and perform statistical analyses, support process validation for late-stage commercial processes, provide technical input for deviations and change controls, identify continuous improvement opportunities, collaborate with cross-functional teams (Manufacturing, Quality, Regulatory, etc.)
Seniority
Mid-level IC (requires Bachelor's + 2 years or Master's)
