Group Leader - Molecular Biology (GMP)
Core
Provide management and direction to laboratory staff, oversee daily GMP operations, and ensure quality and project timelines for cell and gene therapy projects.
Role type
Senior Group Leader, Molecular Biology (GMP)
Builds
Clinical trial services and laboratory operations for life sciences clients
Domain
Life Sciences / Cell and Gene Therapy / GMP Manufacturing
Deliverable
client delivery
Required skills
Molecular biology techniques, method development and validation, leadership, performance management, process improvement, QA metrics, troubleshooting, project management, financial understanding
Preferred skills
Analytical method transfer, qualification, SOP development, mentoring junior staff
Technologies
GMP Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS)
Responsibilities
Prepare and approve study protocols and technical reports; design experiments and troubleshoot technical issues; lead client and FDA audits; manage laboratory resources and project timelines; coordinate with internal functional groups; implement quality systems and SOPs
Seniority
Senior, hands-on IC with leadership responsibilities