Senior Group Leader - Cell Lab
Core
Oversee clinical laboratory testing operations, ensure result accuracy and compliance, and manage/mentor lab staff within a tiered structure.
Role type
Senior Group Leader (Clinical Laboratory Operations)
Builds
Clinical trial laboratory services for global pharma/biotech clients
Domain
Life Sciences / Clinical Research / Cell & Gene Therapy
Deliverable
client delivery
Required skills
Management of tiered organizational structures, resource allocation and scheduling, protocol and report review/approval, data quality and compliance review, audit leadership (client/regulatory), proposal and pricing preparation, SOP development and implementation, client technical consultation, root cause analysis, technical writing, QA metrics knowledge, staff mentoring, GMP/ICH/EMA/FDA regulatory knowledge, analytical method optimization, project management
Preferred skills
Experience in cellular and immunologically based assays, Cell & Gene therapy background
Technologies
LIMS
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 project proposals and negotiate budgets; implement SOPs and quality improvements; communicate quality issues to staff; cultivate collaborative team environment
Seniority
Senior, hands-on IC with management responsibilities
