Radiopharmaceutical Analytical Method Development Scientist

SK Life Science

Paramus (NJ)

On-site

USD 120,000 - 140,000

Full time

14 days+

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Job summary

SK Life Science is seeking a Scientist, Analytical Method Development for Radiopharmaceuticals in Paramus, NJ. This role focuses on developing, validating, and transferring analytical methods for radiopharmaceuticals across development stages.

Collaboration with QA, Manufacturing, and external partners ensures robust, compliant methods. The position requires 7 years in pharma/biotech and 2–3 years in radiopharmaceuticals, with hands-on method development and transfer experience.

Qualifications

Bachelor's degree in Chemistry, Biology, Life Sciences, or a related discipline.
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.

Responsibilities

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 analytical techniques including HPLC/UPLC, radio-HPLC, GC, TLC, radio-TLC, spectroscopy, and wet chemistry methods.
Author and execute method qualification, validation, and verification protocols per 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 robustness and reproducibility.
Support testing of precursors and radiolabeled finished drug products, including identity, purity, potency, and impurity profiling.
Collaborate with Radiation Safety Officers 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.
Prepare and review technical reports, method SOPs, validation reports, and specifications.
Contribute to CMC sections of regulatory submissions (IND, CTA, IMPD, NDA/BLA).
Support regulatory interactions, audits, and inspections with analytical expertise and documentation.
Partner with CMC, Process Development, Manufacturing, Quality, and Clinical teams to align analytical strategies.
Support investigation of OOS/OOT results and implement corrective actions.
Drive continuous improvement initiatives in analytical efficiency, data integrity, and method lifecycle management.