Study Lead - GMP, Cell & Gene Therapy
Core
Managing multiple routine GMP projects (release, stability, quality control) for cell and gene therapy, ensuring data integrity and regulatory compliance.
Role type
Senior IC Study Lead (GMP Laboratory)
Builds
Routine study outputs, scientific reports, and quality records for clients in the life sciences industry.
Domain
Life Sciences / Cell & Gene Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, routine analytical testing, data analysis, project management, technical writing, risk assessment, SOP adherence, data integrity principles, troubleshooting, mentoring
Preferred skills
Familiarity with data collection software, Microsoft suite proficiency, experience with analytical instruments
Technologies
Microsoft Word, Excel, Power BI, PowerPoint, Teams, SharePoint
Responsibilities
Manage routine study execution and timelines; review and evaluate data; write protocols and reports; communicate with clients and stakeholders; mentor laboratory staff; ensure audit readiness; escalate non-routine issues.
Seniority
Senior, hands-on IC