Senior Director, Analytical Development

📋 Description

• Define the long-term analytical development strategy, operating model, governance structure, and
• Lead the development and execution of analytical development and external testing strategies for
• Establish phase-appropriate analytical control strategies, including method development
• Serve as a senior enterprise leader for analytical strategy, consulting with Technical Operations
• Build and lead a high-performing analytical organization, directly managing leaders responsible for
• Serve as Generate's senior analytical representative with CDMOs, contract testing laboratories, and

🎯 Requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Molecular Biology, Chemical
• Deep expertise in analytical development and quality control for biologics, including monoclonal
• Demonstrated success developing and implementing phase-appropriate analytical strategies
• Extensive experience with analytical method development, qualification, transfer, validation
• Strong scientific understanding of protein characterization techniques including chromatographic
• Proven experience establishing specifications, comparability strategies, stability programs, and

🎁 Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package