Staff Scientist, Biopharmaceuticals (GMP)
Core
Senior scientific contributor providing expert-level technical leadership and oversight for non-routine analytical testing, method establishment, validation, and transfer in a GMP-regulated biopharmaceutical laboratory environment.
Role type
Staff Scientist (Senior IC)
Builds
Analytical methods, validated testing protocols, and technical solutions for client programs
Domain
Biopharmaceuticals / Analytical Chemistry / GMP
Required skills
Expert knowledge of analytical testing techniques and instrumentation, GMP compliance, complex experimental design and execution, root cause analysis, technical mentorship, regulatory document review, advanced troubleshooting, data integrity management
Preferred skills
Subject matter expertise in specific analytical platforms, ability to define best practices, strategic technical decision-making
Technologies
Laboratory instrumentation, analytical platforms, Microsoft Office
Responsibilities
Provide technical oversight for complex non-routine analytical testing and method establishment; Serve as a senior technical authority and SME for analytical technologies; Guide scientific decision-making for experimental design and data interpretation; Design and oversee complex laboratory experiments, development, and validation activities; Mentor Senior Scientists and staff to develop technical skills; Collaborate with Quality and Program Managers to align execution with regulatory expectations; Participate in client interactions regarding technical strategy and data interpretation
Seniority
Senior, hands-on IC
