Scientist, Analytical Method Development - Radiopharmaceuticals

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

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

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

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

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

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

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+)

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