Aseptic Manufacturing Lead for Cell Therapy

iovancebiotherapeutics; Philadelphia (Philadelphia County); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Iovance Biotherapeutics, Inc. is seeking a Supervisor for Aseptic Manufacturing to oversee production processes and ensure safety and compliance. The role emphasizes timely document review, staff development, and implementing a First-time right program to meet growing demand.

The successful candidate will lead autologous cell therapy manufacturing operations in ISO class 5 cleanrooms, with strong background in cell culture and regulatory requirements. Travel ~10% is expected.

Qualifications

• Minimum BS in biology, biochemistry, bioengineering or related field.
• 5+ years GMP biopharma manufacturing with cell culture experience.
• 2+ years in a Lead/Leadership/Supervisory role desired.
• Strong knowledge of aseptic processing in cleanroom environments.

Responsabilités

• Supervision and development of direct reports (operators), mentoring to foster continuous improvement.
• Schedule and coordinate day-to-day activities according to the production plan.
• Develop deep understanding of current production processes as SME in a specific area.
• Oversee manufacturing to ensure cGMP compliance and proper aseptic techniques.
• Review batch documentation and logbooks for completeness and accuracy.
• Lead on deviations, CAPAs, and training program effectiveness.

Connaissances

GMP manufacturing

Cell culture

Leadership

Training

Aseptic processing

Formation

Bachelor's degree in biology/biochemistry/biotech

Outils

cGMP knowledge

Description du poste

Iovance Biotherapeutics, Inc. is seeking a Supervisor for Aseptic Manufacturing to oversee production processes and ensure safety and compliance. The role emphasizes timely document review, staff development, and implementing a First-time right program to meet growing demand.

The successful candidate will lead autologous cell therapy manufacturing operations in ISO class 5 cleanrooms, with strong background in cell culture and regulatory requirements. Travel ~10% is expected.