QC Lab Ops & Operational Readiness Senior Specialist
Core
Planning and executing end-to-end operational readiness for a new QC laboratory manufacturing high-potent biologics and ADCs, transitioning to steady-state operations.
Role type
Senior IC laboratory operations specialist (operational readiness)
Builds
A compliant, ready-to-operate QC laboratory for biologics manufacturing
Domain
Biotechnology / Pharmaceutical manufacturing (High Potent Compounds, ADCs)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Laboratory start-up project management, cGMP compliance, LIMS implementation, stability program operations, inventory management, deviation/OOS investigation, change control, risk analysis, Lean Six Sigma
Preferred skills
PMP certification, advanced degree in Chemistry/Biochemistry/Engineering, experience with health authority inspections
Technologies
LIMS, Veeva, Kneat, Biovia
Responsibilities
Build and govern the QC laboratory operations readiness schedule; Coordinate drafting and approval of SOPs and work instructions; Develop end-to-end sample management processes; Manage inventory control for consumables and reagents; Support stability facility start-up and sample distribution; Ensure compliance with cGMP and regulatory requirements (FDA, EMA, ICH)
Seniority
Senior, hands-on IC
