Senior Director, Analytical Development

📋 Description

• Define and execute the global analytical development and quality control strategy, aligning
• Serve as the accountable executive for GMP analytical operations, ensuring inspection-ready
• Act as a senior CMC leader on cross-functional program teams, influencing development strategy
• Lead analytical method development, validation, transfer, and lifecycle management, with an initial
• Own dissolution strategy, including discriminating method development, validation, and preparation
• Author and review analytical content for NADA CMC technical sections, including method validation

🎯 Requirements

• Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline.
• 18+ years of progressive experience in pharmaceutical analytical development and quality control
• Demonstrated experience spanning early-stage development, clinical programs, commercial launch, and
• Proven success building and leading analytical development and/or QC organizations, including
• Extensive hands-on expertise in analytical method development, phase-appropriate validation, method
• Direct experience engaging with the FDA on regulatory submissions, responses, meetings, and

🎁 Benefits

• Base salary range of $230,000–$280,000 USD.
• Eligibility for a company equity options grant.
• Full-coverage medical, dental, and vision insurance for employees and dependents.
• $1,000 home office equipment stipend.
• Annual learning budget of $1,200 for books, courses, and professional development.
• Monthly wellness budget of $250, which can be used for eligible wellness-related expenses.