Launch Readiness Lead (AD Ops)
Core
Lead new product introduction and launch readiness for biologics clinical and commercial manufacturing at a single-use facility, overseeing operational, capital, and multi-product activities.
Role type
Senior Launch Readiness Lead (Biologics Manufacturing)
Builds
New biologics drug substance and drug product commercialization
Domain
Biologics manufacturing, pharmaceutical process development, GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing, Drug substance manufacturing, Drug product manufacturing, Formulation, Filling, Process technology transfer, Process validation, Capital project management, Cross-functional team leadership, GMP compliance, Regulatory filing, Risk management, Financial acumen, Lean Six Sigma
Preferred skills
cGMP, GDP, Managed services, Tech transfer core team collaboration
Technologies
Microsoft Office
Responsibilities
Drive site and above-site activities to deliver operational launch milestones and product filing; Define and deliver capital projects meeting timeline, cost, quality, and safety expectations; Develop local implementation strategies and coordinate cross-functional teams (analytical sciences, finance, engineering, validation, regulatory); Represent launch readiness in Site Leadership Team and global governance meetings; Generate and maintain holistic schedules with resource loading for launch activities.
Seniority
Senior, hands-on IC with strategic decision-making
