Cell Therapy GMP Operations Lead

Roswell Park Comprehensive Cancer Center; Buffalo (NY); Vor Ort; USD 111.000 - 136.000; Vollzeit

Zusammenfassung

Roswell Park Comprehensive Cancer Center in Buffalo, NY seeks a Technical Operations Manager to lead CAR-T and other cell therapy manufacturing within a GMP facility. You will oversee day-to-day operations, coordinate development activities, and ensure compliance with cGMP and safety standards while optimizing productivity and profitability.

The role requires advanced degree in health/ science and significant GMP manufacturing experience; preferred lean, agile delivery, and CDMO exposure.

Qualifikationen

• PhD with 3 years GMP manufacturing experience or Master’s with 5 years GMP manufacturing experience.
• Degrees must be conferred by an accredited institution or equivalent per Roswell Park/HRI standards.

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 of cell therapy programs, including manufacturing, facilities cleaning and maintenance.
• Coordinate process and analytical development activities and ensure compliance with cGMP and safety protocols.
• Partner with departments to optimize production processes and implement innovative productivity improvements.
• Assist Technical Operations management with budgets, statements of work, and reporting documents.

Kenntnisse

Scrum Master

Agile delivery

Lean Six Sigma

CDMO experience

Quality systems awareness

Ausbildung

PhD in health or science related field

Master's degree in health or science related field

Tools

TrackWise

MasterControl

Jobbeschreibung

Roswell Park Comprehensive Cancer Center in Buffalo, NY seeks a Technical Operations Manager to lead CAR-T and other cell therapy manufacturing within a GMP facility. You will oversee day-to-day operations, coordinate development activities, and ensure compliance with cGMP and safety standards while optimizing productivity and profitability.

The role requires advanced degree in health/ science and significant GMP manufacturing experience; preferred lean, agile delivery, and CDMO exposure.