Senior Director of Analytical Development
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Job Summary
Providing strategic leadership in a remote capacity, the full-time Senior Director of Analytical Development will manage all analytical development across the pipeline, author analytical content for regulatory submissions, and build a high-performing QC organization while ensuring compliance with FDA requirements.
Key responsibilities
- Set and execute the global analytical development and quality control strategy aligned with corporate objectives
- Lead the development, validation, and lifecycle management of analytical methods for small-molecule oral solid dosage products
- Serve as a senior analytical subject-matter expert in interactions with regulatory agencies, including FDA CVM
Required qualifications
- Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline
- 18+ years of experience in analytical development and quality control for pharmaceutical products
- Proven success in building and leading analytical and QC organizations
- Direct experience with FDA regulatory submissions and inspections
- Extensive knowledge of analytical method development and GMP QC operations
Complete Job Description
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