Senior Scientist, Radiopharmaceutical Method Development

SK Life Science, Inc.; Paramus (NJ); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

401(k) plan with match

Medical, dental, and vision coverage

Job summary

SK Life Science, Inc. is seeking a Scientist, Analytical Method Development for Radiopharmaceuticals responsible for development, optimization, validation, and transfer of analytical methods supporting radiopharmaceutical products across early- and late-stage development.

The role sits within the CMC organization and collaborates with Quality, Manufacturing and external partners to ensure robust, compliant, and transferable methods.

Qualifications

• 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.

Responsibilities

• Develop, optimize, and qualify analytical methods to support radiopharmaceutical drug substance and drug product development in collaboration with CDMOs and internal teams.
• Design methods suitable for radioactive materials, accounting for decay, sensitivity, speed, and radiation safety considerations.
• Author and execute method qualification, validation, and verification protocols per ICH and regulatory expectations; lead or support method transfers to QC labs and external sites.
• Support testing of precursors and radiolabeled finished drug products, including identity, purity, potency, and impurity profiling; ensure compliant handling with Radiation Safety Officers.
• Prepare and review technical reports, SOPs, validation reports, and specifications; contribute to regulatory submissions and respond to audits.

Skills

Analytical method development

Radiopharmaceuticals

Analytical chemistry

Technical writing

Education

Bachelor’s degree in Chemistry, Biology, Life Sciences, or related

Tools

HPLC/UPLC

radio-HPLC

GC

TLC

radio-TLC

Spectroscopy

Wet chemistry

Job description

SK Life Science, Inc. is seeking a Scientist, Analytical Method Development for Radiopharmaceuticals responsible for development, optimization, validation, and transfer of analytical methods supporting radiopharmaceutical products across early- and late-stage development.

The role sits within the CMC organization and collaborates with Quality, Manufacturing and external partners to ensure robust, compliant, and transferable methods.