Senior Group Leader - Cell Lab
Core
Oversee clinical laboratory testing operations, ensure result accuracy and compliance, and manage/mentor lab staff for a global clinical research organization.
Role type
Senior Group Leader (Laboratory Operations)
Builds
Clinical trial laboratory services and data for global pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Research / Cell & Gene Therapy
Required skills
Management of tiered organizational structures, Resource allocation and scheduling, Protocol and report review, Data quality and compliance auditing, Client technical meetings and support, SOP development and change management, Root cause analysis, Technical writing, GMP/ICH/USP/FDA/EMA regulatory knowledge, Analytical method optimization
Preferred skills
Cell & Gene therapy experience, Leadership and mentoring, Project solution driving, Collaborative environment cultivation, Time and project management
Technologies
LIMS, GMP systems, Analytical instrumentation
Responsibilities
Manage supervisors and analysts, Allocate and schedule lab resources, Review and approve study protocols and reports, Lead client and regulatory audits, Respond to client technical needs, Prepare proposals and negotiate budgets, Implement SOPs and quality improvements, Communicate quality issues to staff
Seniority
Senior, hands-on IC with management responsibilities