Scientist 2, Separations and Biophysics Assays
BioMarin Pharmaceutical Inc.
August 31, 2026
On-site
Novato, CA
$118,400 - $162,800 USD yearly
Clinical Research and Development
Summary: Scientist 2 (Analytical Sciences, Glycan Analysis and Biophysical Characterization) supporting protein/enzyme replacement therapy, small molecule, peptide, and oligo programs.
Responsibilities:
- Lead analytical method development, qualification, transfer, and lifecycle remediation for clinical/commercial CMC across multiple modalities.
- Support pre- and post-IND regulatory submissions by authoring/reviewing analytical sections and responding to agency queries.
- Develop/optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based methods focused on glycan analysis.
- Prepare, review, and approve analytical/technical protocols and reports; document data for inspections.
- Participate in general lab and instrument maintenance; mentor junior scientists/research associates as needed.
Required Skills:
- Strong glycan characterization expertise (method development/qualification/troubleshooting/data interpretation) using LC-MS, CE-based methods, cIEF, HILIC-FLD/MS, and orthogonal techniques.
- Hands-on separation science and MS (LC-MS; SEC, IEX, RP, HILIC) with detection platforms (UV, CAD, ELSD, FLD, MS); ability to integrate multi-platform data.
- Experience with phase-appropriate analytical methods for DS/DP, formulation development, process characterization, comparability, and control strategy across clinical/commercial stages.
- Working knowledge of USP, ICH, and global regulatory expectations (FDA/EMA/PMDA/others).
- Excellent scientific communication; strong problem-solving and ability to work in a fast-paced environment.
Desired Skills:
- Advanced workflows (CE-SDS, icIEF/cIEF, intact mass, peptide mapping, glycan profiling).
- Regulatory submission experience (IND/BLA/MAA and responses).
Education:
- PhD in Chemistry/Biochemistry/pharmaceutical chemistry or related + 4+ years relevant post-graduate experience (or Master’s + 8+ years).
Responsibilities:
- Lead analytical method development, qualification, transfer, and lifecycle remediation for clinical/commercial CMC across multiple modalities.
- Support pre- and post-IND regulatory submissions by authoring/reviewing analytical sections and responding to agency queries.
- Develop/optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based methods focused on glycan analysis.
- Prepare, review, and approve analytical/technical protocols and reports; document data for inspections.
- Participate in general lab and instrument maintenance; mentor junior scientists/research associates as needed.
Required Skills:
- Strong glycan characterization expertise (method development/qualification/troubleshooting/data interpretation) using LC-MS, CE-based methods, cIEF, HILIC-FLD/MS, and orthogonal techniques.
- Hands-on separation science and MS (LC-MS; SEC, IEX, RP, HILIC) with detection platforms (UV, CAD, ELSD, FLD, MS); ability to integrate multi-platform data.
- Experience with phase-appropriate analytical methods for DS/DP, formulation development, process characterization, comparability, and control strategy across clinical/commercial stages.
- Working knowledge of USP, ICH, and global regulatory expectations (FDA/EMA/PMDA/others).
- Excellent scientific communication; strong problem-solving and ability to work in a fast-paced environment.
Desired Skills:
- Advanced workflows (CE-SDS, icIEF/cIEF, intact mass, peptide mapping, glycan profiling).
- Regulatory submission experience (IND/BLA/MAA and responses).
Education:
- PhD in Chemistry/Biochemistry/pharmaceutical chemistry or related + 4+ years relevant post-graduate experience (or Master’s + 8+ years).