Senior Scientist, Large Molecule Analytical & Formulation Dev (Characterization)

Key Accountabilities / Core Job Responsibilities Lead internal large molecule CMC-focused mass spectrometry and extended characterization activities, including primary sequence determination, PTM analysis, and higher order structure characterization. Develop phase-appropriate product extended characterization strategies, including early vs. late phase structure elucidation and characterization of product variants and forced degraded samples. Hands‑on LC‑MS based characterization to support comparability, CQA assessments, structure-function-activity relationships, and product understanding. Author and review technical development documents and relevant sections of health authority filings. Maintain timely and accurate lab records. Provide rapid analytical support for cell‑line, bioprocess, and formulation development. Support late phase analytical development and product characterization for large molecule CMC programs. Contribute to overall analytical control strategy for commercialization of complex biotherapeutics. Oversee product characterization strategy/execution for structure, forced degraded panels, and minor variants. Perform critical quality attribute (CQA) assessments. Oversee analytical method transfer, qualification, and validation at internal/external QC labs. Qualifications / Skills PhD in Analytical Chemistry, Chemical Engineering, Biophysics, or related field + 3+ years CMC-focused analytical development in protein therapeutics (MS 8+ or BS 10+ years). In‑depth, hands‑on mass spectrometry method development and application (intact/reduced MS, subunit analysis, peptide mapping, N‑/O‑glycosylation profiling, disulfide linkage determination, LC‑MS/MS). Experience with protein therapeutic variants and forced degradation samples. Experience authoring IND/BLA sections (e.g., analytical comparability, structure elucidation, justification of specifications). Experience with analytical protein characterization/biophysical methods (e.g., HPLC, cIEF, capillary electrophoresis, LC/MS MAM, peptide mapping, spectrophotometry, light scattering). Track record transferring/qualifying analytical methods, developing control strategies, and supporting health authority submissions. Strong DoE/statistical approaches for method development, robustness testing, and data analysis. Excellent communication, collaboration, organization, and problem‑solving. Compensation / Benefits Salary range: $147,000.00–$191,000.00; competitive total rewards including 401k, healthcare coverage, ESPP, and other benefits. #J-18808-Ljbffr Scorpion Therapeutics