Scientist, Analytical Operations

We are seeking a talented and highly motivated **Research Scientist** to join our **Pivotal and Commercial Biologics Characterization** team within **Biologics Pivotal and Commercial Analytical Development**. This role requires broad experience in analytical development across all stages—from early development to commercial launch—as well as regulatory filing experience with the FDA and EMA. A deep understanding of technologies used in the characterization of biological products is essential.* BS degree in Biochemistry or a related discipline with at least six (6) years of experience OR* MS degree in Biochemistry or a related discipline with at least four (4) years of experience,* Strong knowledge of mass spectrometry, experimental design, and assay development.* Excellent communication skills (verbal, technical writing, and interpersonal).* Strong organizational and planning skills.* Ability to think critically and creatively, work independently, and resolve problems using appropriate resources.* PhD in Biochemistry or a related discipline with 0+ years of experience* Subject matter expertise in establishing comprehensive control strategies for biologics products.* Familiarity with technologies such as:

+ Mass spectrometry

+ Analytical ultracentrifugation (AUC)

+ Size exclusion chromatography (SEC)

+ Reversed phase chromatography

+ Ion exchange chromatography (IEX)

+ Capillary gel electrophoresis (CGE)

+ Light scattering techniques (DLS, MALS)

+ Molecular analysis* Knowledge of FDA and ICH guidelines related to registration, quality, and compliance for drug substances and drug products.* Experience with mass spectrometry analysis software (Protein Metrics, Thermo BioPharma Finder, Skyline).* Proficiency in data analysis and visualization tools (Python, R, JMP, Spotfire). #J-18808-Ljbffr