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 supporting process development and product characterization across clinical and commercial CMC phases.
- Support pre- and post-IND regulatory submissions by authoring/reviewing analytical sections and responding to regulator questions.
- Develop/optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based methods with focus on glycan analysis.
- Prepare, review, and approve analytical/technical protocols and reports.
- Document experiments and data electronically for inspection readiness.
- Participate in general lab and instrument maintenance.
- Mentor junior scientists/research associates as needed.
Required Skills
- Deep expertise in glycan characterization/analysis (LC-MS, CE-based methods, cIEF, HILIC-FLD/MS, orthogonal techniques) for biologics/complex modalities.
- Hands-on separation science and MS (LC-MS; SEC, IEX, RP, HILIC) with detection (UV, CAD, ELSD, FLD, MS) and ability to integrate multi-platform data.
- Experience developing phase-appropriate analytical methods for DS/DP, formulation, process characterization, comparability, and control strategy (clinical to commercial).
- Working knowledge of USP, ICH, and global regulatory expectations (FDA, EMA, PMDA, etc.).
- Strong scientific communication, problem-solving, and ability to thrive in a fast-paced environment.
Education
- PhD in Chemistry/Biochemistry/pharmaceutical chemistry (or related) with 4+ years post-graduate experience (OR)
- Masterβs degree with 8+ years post-graduate experience.