Sr. Manager of Analytical Manager
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-01-22
Listing for:
Barrington James
Full Time
position Listed on 2026-01-22
Job specializations:
-
IT/Tech
Data Analyst, Data Science Manager, Data Scientist, Data Security
Job Description & How to Apply Below
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.
Key Responsibilities- 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
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