Scientist – Process Development, Drug Substance Lifecycle
Core
Lead process characterization, validation, and lifecycle management for biologics programs from development through commercial manufacturing.
Role type
Scientist, Process Development (Biologics)
Builds
Biologics drug substance for clinical and commercial manufacturing
Domain
Biopharmaceuticals / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process characterization, Process validation, Continued process verification, Comparability assessments, Lifecycle change management, Risk reduction, Technical protocol authoring, cGMP compliance, Cross-functional collaboration, Statistical analysis
Preferred skills
Biologics development experience, PPQ experience, JMP/Minitab/Excel proficiency, Client-facing project support
Responsibilities
Lead process characterization activities for development, validation, and commercial-stage biologics programs; Support process validation, continued process verification, comparability assessments, and lifecycle change management; Analyze process performance data, identify improvement opportunities, and drive risk reduction initiatives; Serve as a technical subject matter expert for assigned programs and client interactions; Author and review technical protocols, reports, validation documents, and regulatory support documentation; Support investigations, CAPAs, change controls, and quality system activities in a cGMP environment; Collaborate with cross-functional teams to ensure successful technology transfer and commercial manufacturing support.