Sr Scientist, GMP Analytical Testing

Senior Scientist role at Thermo Fisher Scientific focused on validating and implementing analytical methods for pharmaceutical materials in a GMP environment. The position involves method development, instrumentation operation, regulatory compliance documentation, and collaboration with multi-disciplinary teams supporting drug development from discovery through commercialization.

Responsibilities

• Develop, validate, and implement analytical methods using modern instrumentation such as HPLC, UPLC, GC, and dissolution systems
• Transfer validated methods to customer quality control labs and manage method transfer coordination
• Perform analytical testing on development, clinical, and stability samples per established protocols and specifications
• Troubleshoot instrumentation and resolve method performance issues of routine complexity
• Document laboratory work in notebooks with GLP/GMP compliance and prepare technical reports for regulatory submissions

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Material Science, Immunology, Biology, or similar field with 4+ years relevant experience
• Master's degree in lab sciences with 2+ years relevant experience, or PhD
• Hands-on experience with separation techniques including HPLC, UPLC, and GC
• Experience with dissolution, Karl Fischer titrations, and analytical testing methods
• Proficiency in laboratory investigation and documentation of out-of-specification results
• Knowledge of GLP/GMP requirements and regulatory documentation standards
• US work authorization without sponsorship required