Group Leader, Biopharmaceuticals (GMP)
Core
Provide management and direction to laboratory staff, oversee daily operations, and ensure quality and project timelines for biopharmaceutical GMP projects.
Role type
Senior Group Leader, Biopharmaceutical Laboratory Operations
Builds
Biopharmaceutical study protocols, reports, and data for clinical research clients
Domain
Biopharmaceuticals / Clinical Research / GMP Laboratory Services
Deliverable
client delivery
Required skills
Leadership, performance management, process improvement, QA metrics, analytical method optimization, project management, financial understanding, proposal development, SOP implementation
Preferred skills
Technical troubleshooting, mentoring junior staff, business development collaboration
Technologies
Laboratory information systems, financial management tools, quality management systems
Responsibilities
Prepare and approve study protocols and final reports; design experimental studies and troubleshoot technical issues; review data for quality and compliance; manage laboratory resources and project schedules; lead client and FDA audits; coordinate with internal functional groups; implement SOPs and quality system improvements.
Seniority
Senior, hands-on IC with leadership responsibilities