Senior Study Lead, Biopharmaceuticals (GMP)
Core
Overseeing and managing multiple complex or large-scale routine projects (release, stability, or quality control) in a GMP laboratory environment.
Role type
Senior Study Lead (Biopharmaceuticals)
Builds
Routine testing outputs, quality records, and compliance documentation for clients.
Domain
Biopharmaceuticals / Laboratory Services / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, routine analytical testing, project management, data trend analysis, risk-based assessments, audit readiness, technical documentation, stakeholder communication, team mentorship, process optimization
Preferred skills
Power BI, advanced problem-solving, strategic improvement planning
Technologies
Microsoft Office (Word, Excel, PowerPoint, Teams, SharePoint), Power BI
Responsibilities
Draft and approve technical documents and protocols; manage project study plans and strategies; lead execution and coordination of routine projects; hold decision-making authority for investigations and deviations; communicate technical information to clients; lead audit readiness efforts; train and mentor staff on compliance and problem-solving; ensure data integrity and regulatory alignment.
Seniority
Senior, hands-on IC with leadership responsibilities