Manager QC Development
Core
Leading a team to develop, optimize, and validate Quality Control (QC) methods and bio-chemical processes for reagent and kit qualification in a CLIA laboratory.
Role type
Senior IC manager of QC development
Builds
Validated QC methods and optimized bio-chemical processes for reagent and kit release
Domain
Clinical laboratory / Molecular biology / NGS assays
Required skills
Molecular biology, NGS-based laboratory assays, reagent and quality control management, technical writing, personnel management, process optimization
Preferred skills
Assay development, CLIA/FDA laboratory support, data analysis for method validation
Technologies
NGS, CLIA laboratory systems
Responsibilities
Develop and optimize QC tests and bio-chemical processes; Analyze data and prepare documentation for QC method validation; Author and revise QC testing SOPs and reports; Oversee technical transfer of new product QC methods from R&D to Operations; Provide technical support for deviations and non-conformance issues; Manage team performance and development
Seniority
Manager, hands-on leadership