Senior Engineer - Drug Substance Technology & Engineering
Core
Provide downstream purification manufacturing support for clinical and commercial biologics drug substance products, including technology transfer, process optimization, and manufacturing execution.
Role type
Senior IC downstream process engineer with people management
Builds
cGMP clinical and commercial biologics drug substance products
Domain
Biopharmaceutical manufacturing / Downstream purification
Required skills
Downstream purification processes, Technology transfer, Process development, Scale-up, Process optimization, cGMP compliance, Root-cause analysis, Statistical analysis, Equipment utilization, Regulatory support
Preferred skills
Leadership of downstream teams, Cross-functional collaboration, Process validation, PPQ, Continued process verification, Risk assessment, Troubleshooting complex process issues
Technologies
Chromatography, Viral filtration, UF/DF, Sterile filtration, Design of experiments
Responsibilities
Lead technical support for downstream purification processes; Execute technology transfer and manufacturing readiness activities; Provide on-floor manufacturing support and technical escalation; Monitor process performance and lead problem resolution; Lead or support deviations, investigations, and CAPAs; Mentor less experienced engineers in downstream process knowledge
Seniority
Senior, hands-on IC with people management
