Senior Scientist , Analytical Development

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.

• 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.

• 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.

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