About the role
TL;DR
Perform laboratory testing in a fast-paced GMP environment.
- •The Quality Control
- •Analytics department supports a growing portfolio of cell and gene therapy products.
- •We are recruiting for a QC Analyst I to perform laboratory testing in a fast-paced GMP environment.
- •Key Responsibilities Perform laboratory testing with a focus on UHPLC-based biophysical analytical methods and PCR-based molecular methods.
- •Support the development, qualification, and execution of analytical methods for GMP release and characterization testing.
- •Work cross-functionally with Analytical/Process Development, Manufacturing, and Quality Assurance to ensure methods meet regulatory and compendial expectations.
- •Manage time effectively and complete assigned analytical tasks in a collaborative environment.
- •Contribute to the development and optimization of analytical methods supporting CGT safety, identity, purity, strength, and quality testing.
- •Requirements Strong background in UHPLC-based biophysical analytical methods and PCR-based molecular methods.
- •Experience in a GMP environment is highly desirable.
- •Ability to work effectively in a cross-functional team.
- •Excellent time management and organizational skills.
- •Commitment to patient safety and regulatory compliance.
Domain expertise
biotech