Staff Scientist - Biopharmaceuticals, GMP
Core
Senior technical leadership for non-routine analytical development, validation, transfer, and complex investigations in a GMP laboratory setting.
Role type
Staff Scientist (Senior IC technical lead)
Builds
Analytical methods, validated testing protocols, and technical solutions for biopharmaceutical clients
Domain
Biopharmaceuticals / Analytical Chemistry / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Expert knowledge of analytical testing techniques and instrumentation, GMP compliance, complex experimental design, root cause analysis, technical mentorship, data integrity management, regulatory expectations, advanced troubleshooting, scientific decision-making
Preferred skills
Subject matter expertise in specific analytical platforms, method establishment, optimization of scientific capabilities, defining best practices
Technologies
Laboratory instrumentation, Microsoft Office (Word, Excel, PowerBI, PowerPoint, Teams, SharePoint), laboratory data systems
Responsibilities
Provide technical oversight for complex non-routine analytical testing and method establishment, Serve as SME for analytical technologies, Guide scientific decision-making and experimental design, Review and approve technical documents for quality and compliance, Design and oversee complex laboratory experiments and validation, Mentor Senior Scientists and staff, Support resolution of complex technical issues and investigations, Collaborate with Quality and Program Managers to align execution with objectives
Seniority
Senior, hands-on IC with mentorship responsibilities
