Senior Manager, QC
Benefits
Unlimited PTO
Similar Jobs
See allAssociate Director, CMC Quality Assurance
Immunovant, Inc.
GMP
Quality Assurance
Regulatory Compliance
Auditor I, Clinical Quality Assurance
Iovance Biotherapeutics
Global
GCP
GMP
Regulatory Compliance
Principal Scientist, CMC Analytical
Loyal
US
Analytical Chemistry
Regulatory Filings
CGMP
Director, Quality Systems and Compliance
Loyal
US
Quality Management Systems
Computer System Validation
Regulatory Affairs
Key Responsibilities:
- Oversee GMP testing at CMOs and third-party labs for raw materials, in-process, and drug substance.
- Review analytical source data to ensure data integrity and compliance.
- Manage technology transfers and method improvements.
Requirements:
- Bachelor's or advanced degree in Biology, Chemistry, or related fields with 6+ years of biopharmaceutical QC experience.
- Strong understanding of GMP regulations from FDA, EMA, and ROW.
- Knowledge of analytical techniques such as HPLC and capillary electrophoresis.
Work Environment:
- Dynamic, interactive, fast-paced, and entrepreneurial environment.
- Remote-based with access to NYC/NC offices; domestic travel up to 15%.
Immunovant, Inc.
Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. They are a publicly traded, clinical-stage biopharmaceutical company with a dynamic, fast-paced, entrepreneurial culture.