Sr Director, Analytical Development

Role: Senior Director of Analytical Development, providing strategic and technical leadership across the pipeline from discovery to commercialization. Responsibilities: oversee end-to-end, phase-appropriate analytical methods and control strategies, enhance technology platforms, partner with cross-functional teams (Regulatory, Quality, Manufacturing), manage module content for regulatory submissions, and lead organizational development. Requirements: Ph.D. in Chemistry, Analytical Chemistry, or related field; 12+ years post-graduate or 14+ years with a BA/BS, with extensive expertise in pharmaceutical/biopharmaceutical analytical development, including chromatography, mass spectrometry, and method validation. Proven senior leadership experience leading technical teams, with a strong knowledge of cGMP, data integrity, and global regulatory standards. High-value: leadership in biopharma analytical sciences, supporting biologics or small molecules, with involvement in IND/CTA, NDA/BLA filings; experience with regulatory interactions and technology innovation. Work setup: not specified, but requires collaboration across internal departments and external partners.