Scientist - Process Development, Drug Substance Lifecycle
Core
Develop and implement downstream processing methodologies and analytical procedures for biologics drug substances, ensuring transferability to cGMP manufacturing and driving lifecycle improvements.
Role type
Senior IC process development scientist (biologics)
Builds
Downstream processing units and analytical procedures for commercial biologics manufacturing
Domain
Biopharmaceutical manufacturing / Process Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
chromatography (all modes), filtration (viral, tangential flow, normal flow), process scale-up, viral clearance validation, technology transfer, cGMP compliance, data analysis, SOP authoring
Preferred skills
CMC lifecycle management (pre-approval, launch, post-approval), industrial troubleshooting of process skids
Technologies
AKTA platform, chromatography workstations, process skids
Responsibilities
Execute purification experiments including automated chromatography and filtration; troubleshoot and initiate corrective actions; author and review technical documents for regulatory compliance; train and mentor team members on laboratory techniques and procedures; lead client development projects and provide technical support in meetings; critically analyze complex experimental data to drive process improvements
Seniority
Senior, hands-on IC
