Senior Scientist I, Analytical Development

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

Responsibilities:

• Work independently and collaboratively with project teams to deliver accurate, high-quality analytical results.
• Provide technical leadership, guidance, and mentorship to junior scientists.
• Serve as Analytical Project Coordinator or Lead; take ownership of analytical activities (planning, prioritizing, coordinating testing to meet timelines).
• Independently design, develop, optimize, and validate analytical methods for drug substance/API and drug product development.
• Develop specifications and test methods for raw materials, in-process materials, intermediates, drug substances, and drug products.
• Lead analytical activities supporting process development, impurity characterization, GLP toxicology studies, and cGMP clinical trial materials.
• Analyze/interprete complex data, troubleshoot technical challenges, and recommend follow-up activities.
• Prepare/review technical documentation (test methods, development/validation protocols and reports, SOPs, presentations).
• Communicate status, results, risks, and recommendations to project teams and management.
• Ensure work is performed per SOPs, cGMP requirements, regulatory guidelines, and industry standards.
• Contribute to continuous improvement; perform other duties as assigned.

Requirements:

• Ph.D. (2+ yrs), M.S. (10+ yrs), or B.S. (12+ yrs) in Chemistry or related field.
• Analytical method development, optimization, qualification, and validation for pharmaceutical drug substance and drug product.
• Experience developing analytical methods/specifications for raw materials, intermediates, drug substances, and drug products.
• Proficiency with instrumentation/techniques: HPLC, GC, FTIR, UV/Vis, LC/MS, Karl Fischer (KF).
• Strong knowledge of instrumentation principles, test methodologies, and method validation.
• Strong understanding of CMC regulatory requirements and applicable cGMP, ICH, and FDA/CDER guidelines.
• Knowledge of synthetic organic chemistry principles; strong judgment, problem-solving, data interpretation.
• Excellent organizational skills, communication, attention to detail, data quality/integrity; ability to work independently and cross-functionally.
• Candidates must have current, valid authorization to work in the country where this role is located.

Preferred:

• Experience mentoring/training junior scientists.
• Experience serving as analytical project lead/coordinator.
• Experience supporting analytical activities across multiple stages of drug development.
• Demonstrated ability to influence scientific direction and communicate technical recommendations.

Benefits/Pay:

• Wisconsin pay range: $115,000 USD - $135,000 USD.
• Competitive salaries and an excellent benefit package.