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.
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.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.