Senior QC Scientist - Biopharma (Remote)

IMVT Corporation; United States; Remote; USD 165,000 - 185,000; Full time

Job summary

Immunovant seeks a Senior Scientist, QC to provide quality oversight of Quality Control laboratory activities and ensure adherence to global GxP regulations. The role reports to the Senior Quality Control Director and leads QC activities across testing at CMOs and contract laboratories.

The Senior Scientist, QC collaborates with CMC Manufacturing, Quality Assurance, and CMC Regulatory Affairs to meet regulatory requirements and strategic quality goals, with remote work access to NYC/NC and up to

Qualifications

• Experience in biopharmaceutical analytical and QC operations.
• Experience managing third-party laboratories.
• Knowledge of FDA/EMA/ROW GMP regulations and expectations.
• Experience with method transfer and validation per ICH guidelines.

Responsibilities

• Oversee GMP testing at CMOs/third‑party testing sites for materials and drug substance.
• Verify/review analytical data to ensure integrity and compliance for product release.
• Ensure qualification/validation of QC test methods with Analytical Development.
• Manage tech transfers and method improvements for GMP‑compliant methods.
• Lead OOS investigations, deviations, CAPAs, and risk assessments.

Skills

GMP compliance

Quality control

Data integrity

Analytical expertise

Vendor management

Cross-functional collaboration

Education

Bachelor or higher in Biology, Chemistry, or related field

Tools

JMP

MS Office

Veeva Quality Docs

Empower

LIMS

Job description

Immunovant seeks a Senior Scientist, QC to provide quality oversight of Quality Control laboratory activities and ensure adherence to global GxP regulations. The role reports to the Senior Quality Control Director and leads QC activities across testing at CMOs and contract laboratories.

The Senior Scientist, QC collaborates with CMC Manufacturing, Quality Assurance, and CMC Regulatory Affairs to meet regulatory requirements and strategic quality goals, with remote work access to NYC/NC and up to