Aseptic Manufacturing Supervisor — Cell Therapy Ops Lead

Iovance Biotherapeutics, Inc.; 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 lead production in a cGMP environment. You will oversee aseptic operations, mentor staff, and ensure all materials meet quality standards in ISO-class 5 cleanrooms.

The role requires strong problem solving, documentation, and leadership within a fast-paced cell therapy setting. Responsibilities include developing staff, maintaining batch records, CAPAs, deviations, and SOPs, while ensuring compliance with 21 CFR

Qualifications

• Minimum B.S. in biology, biochemistry, bioengineering, or related field.
• Minimum 5 years' experience in biopharmaceutical GMP manufacturing operations, including cell culture.
• 2+ years in lead/supervisory role preferred.
• Strong knowledge of aseptic processing in cleanrooms and regulatory requirements.

Responsabilités

• Supervise and develop direct reports (operators) to foster continuous improvement and operational excellence.
• Schedule and coordinate daily activities to meet the production plan.
• Develop deep process knowledge and serve as SME in aseptic manufacturing; ensure cGMP compliance.
• Oversee manufacturing, ensuring technicians follow aseptic techniques and cGMP practices.
• Review batch documentation and logbooks for completeness and accuracy.
• Lead documentation efforts, including SOPs, batch records, deviations, and CAPAs.

Connaissances

Leadership

Aseptic processing

cGMP

Training & development

Regulatory documentation

Formation

Bachelor's degree in biology/biochemistry/bioengineering or related field

Description du poste

Iovance Biotherapeutics, Inc. is seeking a Supervisor for Aseptic Manufacturing to lead production in a cGMP environment. You will oversee aseptic operations, mentor staff, and ensure all materials meet quality standards in ISO-class 5 cleanrooms.

The role requires strong problem solving, documentation, and leadership within a fast-paced cell therapy setting. Responsibilities include developing staff, maintaining batch records, CAPAs, deviations, and SOPs, while ensuring compliance with 21 CFR