Study Lead, Biopharmaceuticals (GMP)
Core
Managing multiple routine biopharmaceutical testing projects (release, stability, quality control) to ensure data integrity and regulatory compliance.
Role type
Senior IC Study Lead (Biopharmaceuticals)
Builds
Routine study outputs, scientific reports, and quality records for clients
Domain
Biopharmaceuticals / GMP Laboratory Services
Required skills
GMP compliance, routine analytical testing, data analysis, project management, technical writing, risk assessment, SOP adherence, data integrity, troubleshooting, stakeholder communication
Preferred skills
Mentoring junior staff, process improvement, audit readiness support
Technologies
Analytical instruments, data collection software, Microsoft suite (Word, Excel, PowerBI, PowerPoint, Teams, Sharepoint)
Responsibilities
Manage routine study projects 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
