Scientist, Analytical Method Development - Radiopharmaceuticals

Overview 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 development Design methods suitable for radioactive materials, accounting for decay, sensitivity, speed, and radiation safety considerations Apply 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 expectations Lead or support analytical method transfer to internal QC laboratories, CDMOs, and external testing sites Troubleshoot 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 profiling Collaborate with Radiation Safety Officers (RSO) to ensure compliant handling and testing of radioactive materials Develop 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 specifications Contribute to CMC sections of regulatory submissions (IND, CTA, IMPD, NDA/BLA) related to analytical methods Support 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 timelines Support investigation of OOS/OOT results and implement corrective actions as needed Drive continuous improvement initiatives in analytical efficiency, data integrity, and method lifecycle management Qualifications Required Bachelor’s degree in Chemistry, Biology, Life Sciences, or a related discipline Minimum of 7 years of experience in the pharmaceutical or biotechnology industry 2-3 years of direct experience working with radiopharmaceutical products Strong hands-on experience in analytical method development and characterization Demonstrated 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 field Experience supporting regulatory submissions involving radiopharmaceuticals Familiarity with GMP environments and data integrity requirements (e.g., ALCOA+) Key Competencies Strong analytical and problem-solving skills with attention to detail Ability to work effectively in fast-paced, time-sensitive environments Excellent technical writing and documentation skills Strong collaboration and communication skills across cross-functional teams Commitment to quality, compliance, and scientific rigor Compensation & Benefits The anticipated salary range for this position is $120,000 to $140,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs. In addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion. #J-18808-Ljbffr SK Life Science Inc