Senior Scientist, QC

Responsibilities

• Oversee GMP testing at CMOs and third-party testing sites for raw materials, components, in-process, and drug substance
• Verify and review analytical source data to ensure data integrity and compliance for product release
• Manage technology transfers and method improvements to ensure cGMP compliant methods are implemented
• Provide leadership for OOS investigations, change controls, deviations, CAPAs, and risk assessments
• Review and approve sampling instructions, test methods, specifications, and stability protocols
• Monitor emerging Quality and Regulatory requirements and determine impact to the company
• Ensure contracted laboratories follow appropriate quality practices and participate in regulatory inspections

Requirements

• Bachelor's degree in Biology, Chemistry, or related field with 6 years of experience (or MS with 5 years, PhD with 4 years) in biopharmaceutical analytical or QC operations
• Demonstrated experience managing third-party laboratories
• Strong understanding of analytical GMP regulations (FDA, EMA, ROW)
• Knowledge of protein/mAbs separations (HPLC, capillary electrophoresis, SEC, RP-HPLC/UPLC, IEX, icIEF, CE-SDS)
• Experience with GMP-regulated quality systems including document control, deviations, and CAPAs
• Proficiency with MS Office, Veeva Quality Docs, Empower, and LIMS
• Knowledge of statistics and JMP software

Preferred Qualifications

• Experience working with monoclonal antibody products
• Knowledge of ELISAs, binding assays, and impurity assays (host cell proteins, residual impurities)
• Experience in analytical or microbiology method transfer and validation following ICH guidelines
• Experience with reference standard management

About the Company

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative, targeted therapies.