Scientist 2, Separations and Biophysics Assays

Role: Analytical Scientist supporting protein/enzyme replacement, small molecule, peptide, and oligo programs within BioMarin’s Analytical Sciences team. Objectives include leading development, qualification, transfer, and lifecycle management of glycan and biophysical analytical methods to support clinical and commercial product characterization across multiple modalities. Responsibilities involve developing and optimizing LC-MS, HILIC, CE, cIEF, SEC, IEX, RP chromatography techniques, authoring regulatory submissions, and collaborating with cross-functional teams such as Process Development, Quality, and Regulatory Affairs. Requirements: PhD in Chemistry, Biochemistry, or related with 4+ years (Scientist 2) or equivalent experience; expertise in glycan characterization, analytical method development, troubleshooting, and data integration; hands-on experience with LC-MS, chromatography, and orthogonal techniques; knowledge of GxP, USP, ICH, and global regulatory standards; strong communication and problem-solving skills. Preferred qualifications include experience with advanced characterization techniques like CE-SDS, peptide mapping, and familiarity with regulatory submissions. High-Value: biologics (protein/enzyme therapies), glycan analysis, CMC development, IND/regulatory support, clinical and commercial phases, GxP environment. Work setup: full-time onsite in Novato, CA, with minimal travel (0-5%).