Team Lead, Quality Control, Product Testing & Stability
Core
Lead QC testing activities, stability programs, and sample management for mRNA drug substances and products to ensure compliant release and lifecycle support.
Role type
Senior Team Lead, Quality Control (Pharmaceutical/Biotech)
Builds
Supports product release and lifecycle management for mRNA medicines
Domain
Biopharmaceuticals / mRNA therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, stability program management, sample lifecycle management, analytical data review, OOS investigation, SOP development, audit readiness, cross-functional partnership, digital technology integration
Preferred skills
Generative AI tool integration, method transfer expertise, change control management
Technologies
Electronic laboratory systems, Generative AI tools
Responsibilities
Lead and develop a multidisciplinary QC team; oversee in-process, release, and stability testing; coordinate testing schedules; manage stability programs and data trending; oversee sample management; approve Certificates of Analysis; drive document lifecycle activities; lead investigations, deviations, and CAPAs; partner with QA, Manufacturing, and Regulatory Affairs; act as SME during audits
Seniority
Senior, hands-on IC with team leadership
