Sr. Manager of Analytical Manager

We are partnered with an exciting client based out of San Francisco! They are looking to bring on a Senior Manager of Analytical Development to lead their development for the small molecule pipeline moving through clinical trials! This role will oversee the development, validation and optimization of OSD products.

• Lead development, optimization, and validation of analytical methods for peptide, small-molecule, and oral solid dosage drug products in alignment with ICH guidelines
• Execute advanced analytical characterization including RP-HPLC/UPLC, SEC, LC-MS, peptide mapping, impurity profiling, and identity testing
• Develop and validate stability-indicating methods for complex molecules and finished dosage forms
• Oversee analytical testing for oral solid dosage products, including dissolution, assay, impurities, content uniformity, hardness/friability, and moisture (LOD/KF)
• Manage method transfer, oversight, and issue resolution at external CRO and CDMO partners
• Support specification setting, control strategy development, and authoring of analytical and stability sections for regulatory submissions (e.g., IND/CTA)

• M.S. or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field
• 8+ years of analytical development experience in pharmaceutical or biotech environments
• Strong hands-on experience with peptide and small-molecule analytical techniques, including LC-MS-based methods
• Demonstrated expertise in oral solid dosage testing and characterization
• Proven experience managing analytical transfers and external testing partners
• Experience contributing to CMC analytical sections of regulatory filings