Analytical Scientist Lead: Method Development & Validation

Scorpion Therapeutics; Madison (WI); On-site; USD 115,000 - 135,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior analytical scientist to lead method development and validation for drug substances and products. You will design, optimize, and validate analytical methods and oversee testing to ensure timely delivery with regulatory alignment.

The role requires strong instrumental know‑how (HPLC/LC‑MS/KF), CMC regulatory understanding, and the ability to mentor junior scientists while coordinating cross‑functional teams.

Qualifications

• Analytical method development, optimization, qualification and validation for drug substances and drug products.
• Proficiency with HPLC, GC, FTIR, UV/Vis, LC/MS and Karl Fischer.
• Strong understanding of CMC regulatory requirements and FDA/ICH guidelines.
• Excellent organizational skills and attention to data quality and integrity.
• Ability to work independently and cross-functionally with clear communication.

Responsibilities

• Deliver analytical results and provide technical leadership to project teams.
• Lead analytical activities and coordinate testing to meet timelines.
• Independently design, develop, optimize, and validate analytical methods for drug substances and products.
• Develop specifications and test methods for materials and products.
• Prepare and review technical documentation and reports.
• Communicate status, risks, and recommendations to management.

Skills

Analytical method development

Instrument proficiency

Data interpretation

CMC regulatory knowledge

Problem solving

Cross-functional collaboration

Education

Ph.D. in Chemistry

M.S. in Chemistry

B.S. in Chemistry

Tools

HPLC

GC

FTIR

UV-Vis

LC-MS

Karl Fischer

Job description

Scorpion Therapeutics is seeking a senior analytical scientist to lead method development and validation for drug substances and products. You will design, optimize, and validate analytical methods and oversee testing to ensure timely delivery with regulatory alignment.

The role requires strong instrumental know‑how (HPLC/LC‑MS/KF), CMC regulatory understanding, and the ability to mentor junior scientists while coordinating cross‑functional teams.