Senior Analytical Chemist

About the role

The Senior Analytical Chemist is responsible for independent development of analytical methods suitable for validation, preparing for validation by drafting Test Methods, method validation or verification protocols with ICH, USP, and other regulatory standards in mind.

Responsibilities

• Execute method validations or verifications and draft corresponding reports.
• Transfer validated test methods via hands-on training to the Quality Control department.
• Perform routine testing following established Test Methods.
• Update Standard Operating Procedures to improve lab functions.
• Troubleshoot Analytical R&D laboratory equipment.
• Review colleague’s laboratory notebooks and data.
• Investigate materials and/or processes to support other Polysciences departments.
• Develop methods independently, supported by literature research, to align with customer specifications and business needs.
• Draft test methods, protocols, and reports in alignment with USP, ICH, and other regulatory best practices.
• Perform technical review of junior lab members' laboratory notebooks and data.
• Maintain laboratory equipment, including LCs, GCs, NMR, and GPCs.
• Revise current Standard Operating Procedures and internal documentation to support Continuous Improvement.
• Maintain laboratory notebooks and development reports with ALCOA+ principles.
• Set up and analyze using GC-MS and LC-MS systems.
• Perform NMR, ICP-MS, and GPC analyses and apply theoretical knowledge.
• Mentor junior lab members.

60 – 85% of day-to-day activities will be laboratory-based.

Requirements

• Bachelor's Degree in Chemistry, plus 4+ years of industry experience with at least 3 years developing analytical methods or independently validating them.
• Master’s degree in Analytical Chemistry, plus 1+ years of industrial experience developing analytical methods or performing validation activities.
• Ph.D. in Analytical Chemistry, plus experience developing analytical methods or performing validation activities.
• Experience working in an ISO or FDA-regulated environment.
• Experience verifying and troubleshooting analytical methods in an ISO 9001/ISO 13485 or FDA GMP-regulated environment.
• Knowledge of compendial methods (e.g., USP, EP, ISO, ASTM, ANSI) and ICH guidelines.
• Experience mentoring junior lab members.