Sr. Manager, Cell and Gene Therapy

Senior Manager position in cell and gene therapy laboratory services at a clinical research organization. Oversees line leaders and staff, manages laboratory operations, compliance, and financial performance while driving process improvements in a GMP-regulated environment.

Responsibilities

• Supervise line leaders and manage team resources, mentoring and developing staff
• Engage with clients and business development on proposals, scope definition, and pricing
• Review and approve laboratory investigations, deviations, QA audits, and regulatory submissions
• Monitor revenue projections, billing accuracy, and departmental profitability
• Develop and implement standard operating procedures and quality system improvements

Requirements

• 10+ years of relevant laboratory or clinical science experience
• 5+ years in management or supervisory role
• Thorough knowledge of GMP, GCP, or GLP regulations
• Deep understanding of FDA regulations, ICH guidelines, and clinical laboratory processes
• Strong project budgeting, forecasting, and fiscal management skills
• Excellent leadership, coaching, and communication abilities