Senior Scientist, QC
Remotedxb
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.
#J-18808-LjbffrVacancy posted 3 days ago
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