Senior Director of Analytical Development
virtual vocationsDenver, CO
Senior Director of Analytical Development
Industries
Research and Development in BiotechnologyResearch and Development in the Physical, Engineering, and Life SciencesIn-Vitro Diagnostic Substance ManufacturingAbout the role
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
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JOB OVERVIEW
Experience level
Manager
Location
Denver, CO
Occupation
Natural Sciences Managers
Industry
Research and Development in Biotechnology
Posted
yesterday
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