Engineer I Upstream Drug Substance Technologies and Engineering
Core
Transfer cell culture drug substance processes from lab to manufacturing, support process validation, and provide on-floor technical support for scale-up of biological drug substances.
Role type
Entry-level IC process engineer (biologics upstream)
Builds
Human therapeutic biological drug substances for clinical and commercial manufacturing
Domain
Biotechnology / Biopharmaceutical manufacturing
Required skills
Process development, cell culture, scale-up principles, cGMP manufacturing, troubleshooting, statistical process analysis, deviation management, chromatography, ultrafiltration, virus filtration, aseptic processing, mass oxygen transfer, metabolism profiling
Preferred skills
Chemical/biochemical engineering degree, upstream process knowledge, purification process knowledge, commercial cGMP facility experience, scientific/engineering analysis, technical writing
Technologies
Chromatography, ultrafiltration, normal flow filtration, virus inactivation, virus filtration, cell culture equipment
Responsibilities
Transfer cell culture drug substance processes from laboratory to manufacturing facility, provide process validation support for late-stage commercial processes, provide on-the-floor technical support for scale-up and transfer of process technology, perform routine process monitoring and troubleshooting, perform data trending and statistical process analysis, contribute to process-related deviations (NCs), CAPAs, and change controls, identify operational excellence opportunities, collaborate with Manufacturing, Quality, and Regulatory functions
Seniority
Entry-level, hands-on IC
