Analytical Scientist Ii

Overview

• Develop and validate analytical methods for chromatographic and spectroscopic analyses in a GMP-compliant laboratory environment.
• Lead technical projects and mentor junior chemists to ensure timely completion of laboratory assignments.
• Troubleshoot laboratory instrumentation including HPLC, GC, ICP-MS/OES, and LC-MS/MS.
• Collaborate with cross-functional teams to resolve product quality and compliance issues.
• Perform routine and special request testing of raw materials, finished products, and stability samples.
• Ensure adherence to ISO 17025 test methods and maintain current knowledge of scientific trends.
• Contribute to laboratory safety initiatives and ensure proper handling of hazardous waste.
• Support method transfer protocols and facilitate decision-making through timely testing.

Key Responsibilities & Duties

• Plan and coordinate analytical activities to ensure project success from initiation to completion.
• Develop and validate scientifically sound methods for raw material and product analysis.
• Provide technical support and optimize analytical methods for marketed and developmental products.
• Train and mentor laboratory personnel in proper execution of techniques and data interpretation.
• Troubleshoot and maintain laboratory instruments and software, ensuring operational readiness.
• Collaborate with external departments to investigate quality and compliance issues.
• Perform statistical analysis and design experiments to support laboratory operations.
• Ensure compliance with FDA, ICH guidelines, and GLP/GMP standards.

Job Requirements

• Bachelor’s degree in Chemistry or related field required.
• Minimum of 5 years of technical experience in a GMP environment.
• Proficiency with laboratory instruments including HPLC, GC, ICP-MS/OES, and LC-MS/MS.
• Experience with Empower software and additional laboratory software preferred.
• Knowledge of chromatographic and spectroscopic methods and sample preparation techniques.
• Familiarity with FDA, ICH guidelines, and GLP/GMP standards.
• Strong communication skills and ability to work in a team environment.
• Commitment to laboratory safety and proper handling of hazardous materials.