GMP Cell Therapy Operations Lead

Roswell Park Comprehensive Cancer Center; United States; Vor Ort; USD 111.000 - 136.000; Vollzeit

Zusammenfassung

Health Research, Inc. (HRI) Roswell Park Division seeks a Technical Operations Manager to lead the GMP Engineering & Cell Manufacturing Facility, directing manufacturing of CAR-T and other cell therapies and ensuring compliance with cGMP standards.

You will oversee daily operations, coordinate process development, budget elements, and collaborate across departments to improve productivity and safety, with emphasis on scalable, compliant workflows and external reporting.

Qualifikationen

• PhD in a health, life science, engineering, or related field with the equivalent of five (5) years of full-time GMP cell therapy experience, including eighteen (18) months in a supervisory capacity.
• Master's degree in a health, life science, engineering, or related field with the equivalent of seven (7) years of full-time GMP cell therapy experience, including eighteen (18) months in a supervisory capacity.
• Bachelor's degree in a health, life science, engineering, or related field with the equivalent of nine (9) years of full-time GMP cell therapy experience, including eighteen (18) months in a supervisory capacity.

Aufgaben

• Lead a team responsible for manufacturing CAR-T and other cell therapies within the GMP Engineering & Cell Manufacturing Facility.
• Oversee day-to-day operations, process development activities, and regulatory compliance to cGMP standards.
• Coordinate budgets, statements of work, and reporting for internal and external customers.

Kenntnisse

Leadership

Agile delivery

Quality systems knowledge

Ausbildung

PhD in health/science/engineering

MS in health/science/engineering

Bachelors in health/science/engineering

Tools

TrackWise

MasterControl

Jobbeschreibung

Health Research, Inc. (HRI) Roswell Park Division seeks a Technical Operations Manager to lead the GMP Engineering & Cell Manufacturing Facility, directing manufacturing of CAR-T and other cell therapies and ensuring compliance with cGMP standards.

You will oversee daily operations, coordinate process development, budget elements, and collaborate across departments to improve productivity and safety, with emphasis on scalable, compliant workflows and external reporting.