Scientist, Analytical Method Development - Radiopharmaceuticals

The Scientist, Analytical Method Development for Radiopharmaceuticals, is responsible for the development, optimization, validation, and transfer of analytical methods supporting radiopharmaceutical products across early- and late-stage development. This role requires strong technical expertise in analytical chemistry and a solid understanding of the unique challenges associated with radiopharmaceuticals, including short half-life materials, radioactive impurities, and time-critical testing. The position sits within CMC organization and works closely with Quality, Manufacturing, and external partners to ensure robust, compliant, and transferable analytical methods. Responsibilities Analytical Method Development Working with CDMOs, develop, optimize, and qualify analytical methods to support radiopharmaceutical drug substance and drug product developmentDesign methods suitable for radioactive materials, accounting for decay, sensitivity, speed, and radiation safety considerationsApply a range of analytical techniques, including but not limited to HPLC/UPLC, radio-HPLC, GC, TLC, radio-TLC, spectroscopy, and wet chemistry methods Method Validation & Transfer Author and execute method qualification, validation, and verification protocols in accordance with ICH and regulatory expectationsLead or support analytical method transfer to internal QC laboratories, CDMOs, and external testing sitesTroubleshoot method performance issues during transfer and routine testing, ensuring method robustness and reproducibility Radiopharmaceutical-Specific Testing Support testing of precursors and radiolabeled finished drug products, including identity, purity, potency, and impurity profilingCollaborate with Radiation Safety Officers (RSO) to ensure compliant handling and testing of radioactive materialsDevelop rapid and fit-for-purpose methods suitable for short half-life products and just-in-time manufacturing models Documentation & Regulatory Support Prepare and review technical reports, method SOPs, validation reports, and specificationsContribute to CMC sections of regulatory submissions (IND, CTA, IMPD, NDA/BLA) related to analytical methodsSupport regulatory interactions, audits, and inspections by providing analytical expertise and documentation Cross-Functional Collaboration & Continuous Improvement Partner with CMC, Process Development, Manufacturing, Quality, and Clinical teams to align analytical strategies with development timelinesSupport investigation of OOS/OOT results and implement corrective actions as neededDrive continuous improvement initiatives in analytical efficiency, data integrity, and method lifecycle management Required Qualifications Bachelor’s degree in Chemistry, Biology, Life Sciences, or a related disciplineMinimum of 7 years of experience in the pharmaceutical or biotechnology industry2–3 years of direct experience working with radiopharmaceutical productsStrong hands-on experience in analytical method development and characterizationDemonstrated experience with analytical method transfer to internal or external laboratories Preferred Advanced degree (Master’s or Ph.D.) in Chemistry, Pharmaceutical Sciences, or a related fieldExperience supporting regulatory submissions involving radiopharmaceuticalsFamiliarity with GMP environments and data integrity requirements (e.g., ALCOA+) Key Competencies Strong analytical and problem-solving skills with attention to detailAbility to work effectively in fast-paced, time-sensitive environmentsExcellent technical writing and documentation skillsStrong collaboration and communication skills across cross-functional teamsCommitment to quality, compliance, and scientific rigor