Pharmaceutical Development Manager Jobs in Wisconsin

The Position

This position is within the Analytical Development (AD) group in the CMC Manufacturing organization. The Senior Scientist I, Analytical Development will provide scientific and technical leadership for analytical activities supporting drug substance and drug product development. This role will lead method development and validation activities and support analytical testing for process development, impurity characterization, GLP toxicology studies, and cGMP clinical trial materials.

The Senior Scientist I will work independently and collaboratively across project teams, serve as an analytical lead for assigned programs, and provide technical guidance and mentorship to less experienced scientists. This position reports to Analytical Development management.

Responsibilities

• Work independently and collaboratively with project teams to deliver accurate, high-quality analytical results in support of new and ongoing development programs.
• Provide technical leadership, guidance, and mentorship to junior scientists.
• Serve as Analytical Project Coordinator or Lead for assigned programs, taking ownership of analytical activities, including planning, prioritizing, and coordinating testing to meet project timelines and deliverables.
• Independently design, develop, optimize, and validate analytical methods supporting all stages of 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 and interpret complex analytical data, troubleshoot technical challenges, and recommend appropriate follow-up activities.
• Prepare and review technical documentation, including analytical test methods, development and validation protocols and reports, SOPs, and presentations.
• Communicate project status, analytical results, risks, and recommendations to project teams and management.
• Ensure analytical activities are conducted in accordance with applicable SOPs, cGMP requirements, regulatory guidelines, and industry standards.
• Contribute to continuous improvement of analytical methods, laboratory practices, and departmental processes.
• Perform other duties as assigned.

Requirements

• Ph.D. in Chemistry or a related scientific discipline with 2+ years of relevant experience; M.S. with 10+ years of relevant experience; or B.S. with 12+ years of relevant experience.
• Demonstrated experience in analytical method development, optimization, qualification, and validation supporting pharmaceutical drug substance and drug product development.
• Experience developing analytical methods and specifications for raw materials, intermediates, drug substances, and drug products.
• Demonstrated experience with analytical instrumentation and pharmaceutical development processes.
• Experience independently analyzing complex data, troubleshooting analytical challenges, and recommending appropriate solutions.
• Experience leading analytical activities or serving as an analytical representative on cross-functional project teams.
• Proficiency with analytical techniques and instrumentation such as HPLC, GC, FTIR, UV/Vis, LC/MS, Karl Fischer (KF), and related technologies.
• Strong knowledge of analytical instrumentation principles, test methodologies, and method validation.
• Strong understanding of CMC regulatory requirements and applicable cGMP, ICH, and FDA/CDER guidelines.
• Knowledge of the principles of synthetic organic chemistry.
• Strong scientific judgment, problem-solving, and data interpretation skills.
• Excellent organizational skills with the ability to manage multiple priorities and project timelines.
• Strong written and verbal communication skills.
• Strong attention to detail and commitment to data quality and integrity.
• Ability to work effectively both independently and within cross-functional teams.

Preferred

• Experience providing technical guidance, training, or mentorship to junior scientists.
• Experience serving as an analytical project lead or coordinator for pharmaceutical development programs.
• Experience supporting analytical activities across multiple stages of drug development.
• Demonstrated ability to influence scientific direction and effectively communicate technical recommendations across functions.