A company is looking for a Manager, AS&T.
Key Responsibilities
Oversee and manage quality control deliverables for technology transfer and analytical test method validation
Provide strategic quality oversight and lead analytical QC deliverables across external partners
Compile, review, and analyze assay performance data while investigating analytical problems
Required Qualifications, Training, and Education
Master's or PhD with 6-8 years of relevant experience in pharmaceutical, biologics, or cell therapy
Minimum of 5 years in an FDA regulated industry
Knowledge of cGMP and Data Integrity
Technical expertise in cell-based assays and regulatory requirements
Experience managing method qualifications or validations across multiple external vendors
Quality Control Manager • Colorado Springs, Colorado, United States