Principal Scientist, Large Molecule Analytical
Core
Define analytical strategy and lead a team of scientists to solve complex analytical problems at the interface of biology, chemistry, and lab informatics for biologics API development.
Role type
Principal Scientist, Large Molecule Analytical
Builds
Release, characterization, and stability assays for clinical trial material and product/process development
Domain
Pharmaceutical industry, Biologics Analytical Research & Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical Method Development, Assay Development, Bioanalytical Analysis, Chromatographic Techniques, Clinical Judgment, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Liquid Chromatography (LC), Matrix Management, Mentoring Staff, Method Validation, Personal Initiative, Stability Testing, Technical Writing
Preferred skills
Protein degradation mechanisms, Glycan analysis, Antibody Drug Conjugate method development, High-throughput experimentation
Technologies
Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), Capillary Electrophoresis (CE), Molecular biology, Immunoassay techniques
Responsibilities
Define analytical strategy with group Director, lead team of scientists, develop residual assays using molecular biology/immunoassay, design and direct development/qualification of release/stability assays, author technical reports and regulatory filings, mentor staff and coach peers, execute complex objectives under aggressive timelines
Seniority
Principal, strategy & mentorship