Study Lead, Biopharmaceuticals
Core
Managing multiple routine biopharmaceutical testing projects (release, stability, quality control) and ensuring adherence to GMP and regulatory guidelines.
Role type
Senior Study Lead (Biopharmaceuticals)
Builds
Routine study outputs, scientific reports, protocols, and quality records for clients.
Domain
Biopharmaceuticals / Laboratory Services
Required skills
GMP compliance, routine analytical testing, data integrity, project management, technical writing, data analysis, troubleshooting, mentoring, risk assessment
Preferred skills
Familiarity with data collection software, Microsoft suite proficiency, audit readiness
Technologies
Analytical instruments, detection techniques, Microsoft suite (Word, Excel, PowerBI, PowerPoint, Teams, Sharepoint), data collection software
Responsibilities
Manage multiple routine projects and timelines; communicate updates and technical findings to clients and stakeholders; prepare and review study protocols and reports; collate and evaluate data for accuracy and compliance; monitor daily operations for SOP adherence; provide guidance and training to laboratory staff; support audit readiness and address audit findings; escalate non-routine or complex issues to senior technical staff.
Seniority
Senior, hands-on IC
