Senior Scientist II, Downstream Development (Scale-Up Laboratory Lead)
Core
Lead laboratory-based scale-up activities to develop, optimize, and transfer robust downstream purification processes for biologic drug substances.
Role type
Senior Scientist II, Downstream Development (Scale-Up Laboratory Lead)
Builds
Robust, phase-appropriate downstream processes for biologic drug substance manufacturing
Domain
Biologics CMC development, Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream/purification process development, Process scale-up and scale-down model execution, Technology transfer, AKTA systems expertise (UNICORN software), Large-scale TFF operations, Large column packing (3–20 L), Large-scale filtration operations, Biochemistry and bioprocess engineering principles, Analytical methods (HPLC, CE, UV-based quantitation), Technical writing and scientific data presentation
Preferred skills
Leading downstream scale-up laboratory functions, Supporting transfer to pilot-scale/GMP manufacturing, Experience with monoclonal antibodies and bispecifics, Platform purification strategy advancement, Statistical tools and data analysis
Technologies
AKTA systems (Ready, Ready LX, Avant, Pure), UNICORN software, AxiChrom, QuickScale, BPG, Allegro, Cytiva, Repligen, Single-use technologies (SUMs, pre-packed columns, flow kits)
Responsibilities
Lead downstream scale-up lab activities and non-GMP material generation; Maintain operational readiness of the scale-up lab; Serve as subject matter expert for downstream scale-up and technology transfer; Lead technology transfer activities to internal manufacturing sites and external partners; Drive scientific understanding and execution of downstream unit operations; Design and execute scale-down and scale-up studies; Troubleshoot process and equipment issues; Mentor junior scientists and manage direct reports; Author and review technical reports and regulatory support documents
Seniority
Senior, hands-on IC with leadership responsibilities