Senior Scientist II, CMC BioProcess Purification Development
Core
Design robust, phase-appropriate drug substance purification processes for biologics (mAbs, multispecifics) to support GMP production, clinical studies, and licensure.
Role type
Senior Scientist II, CMC BioProcess Purification Development
Builds
Drug substance purification processes for complex biologic therapies
Domain
Biopharmaceuticals / Downstream Processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
downstream bioprocess unit operations, affinity chromatography, ion-exchange chromatography, hydrophobic-interaction chromatography, virus filtration, tangential-flow filtration, protein biochemistry, separation science, bioprocess engineering, mechanistic modeling, statistical design of experiments, data analytics, regulatory guidance interpretation, peer-reviewed literature review, technical writing, GxP compliance
Preferred skills
advanced bioprocess technologies, viral clearance strategy, cross-functional team leadership, mentoring
Technologies
affinity chromatography, ion-exchange, hydrophobic-interaction chromatography, virus filtration, tangential-flow filtration
Responsibilities
Develop, optimize, characterize, and scale up purification processes for complex biologic candidates; Lead technology transfer to GMP manufacturing sites; Develop viral clearance strategy and oversee studies with contract laboratories; Optimize purification platforms through mechanistic modeling and statistical design of experiments; Conceive and evaluate novel bioprocess technologies; Write technical publications, reports, and regulatory filings; Mentor and train junior scientists
Seniority
Senior, hands-on IC