Analytical Scientist - ICP-MS

Job Responsibilities

• Develop and validate analytical methods on an Inductively Coupled Plasma Mass Spectrometry instrument (ICP-MS) for testing Elemental Impurities present in parenteral radiopharmaceutical drugs and raw materials.
• Collaborate on the development and validation of other methods utilizing alpha spectrometers, gamma spectrometers, mass spectrometers, and ultra-high-performance chromatography.
• Prepare analytical test methods and method validation, verification, and transfer protocols and reports in accordance with applicable guidelines and industry standards (e.g. USP, EP, and ICH).
• Develop and maintain appropriate documentation, including notebooks, protocols, reports, standard operating procedures and associated forms, and data analysis.
• Participate in troubleshooting and investigations of analytical issues, identify root causes, and implement corrective actions.
• Participate in instrument qualification, calibration, and maintenance activities.
• Work closely with other teams to ensure timely delivery of analytical results and support product development and commercialization.
• Participate in method transfer activities from CDMO or internal research facility to QC team, ensuring accuracy and reliability of data.
• Provide technical support to other teams or business units as required.
• Ensure compliance with GMP regulations, safety guidelines, and quality standards.
• Work with RSO to ensure laboratory compliance with the radiation safety programs.
• Source and on-board analytical technologies as required.

Education and Experience

• B.Sc. or M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or relevant scientific field, or an equivalent combination of education and experience.
• Minimum 5 years of experience in analytical method development, validation, verification, and transfer in the pharmaceutical or radiopharmaceutical industry.
• Prior extensive experience with ICP-MS, including verifying USP/ or ICHQ3D(R2) Elemental Impurities and developing and validating custom ICP-MS methods for dozens of elemental impurities that may be present in raw materials.
• Prior experience composing or collaborating on Elemental Impurities risk assessments.
• Prior experience in a GMP pharmaceutical testing laboratory with knowledge of GMP regulations, quality systems, and safety guidelines.

Skills

• Proficient in the use of laboratory instrumentation and Microsoft Office Suite.
• Highly motivated and organized professional with the ability to work independently or in a team environment.
• Strong analytical and problem-solving skills.
• The ability to multi-task and prioritize work based on multiple workflows.
• Excellent written and oral communication skills.
• Excellent professional ethics, integrity, and ability to maintain confidential information.

Physical Demands

• Sit, reach with hands and arms, and talk or hear.
• Lift and/or move up to 40 pounds occasionally.