Supervisor, Aseptic Manufacturing

Responsibilities

• Supervise and develop direct reports, providing mentoring and coaching to foster operational excellence
• Schedule and coordinate day-to-day manufacturing activities to ensure conformance to daily schedules
• Provide oversight of the manufacturing process, ensuring technicians follow cGMP practices and aseptic techniques
• Review batch documentation and logbooks for completeness and accuracy
• Author and revise documentation including SOPs, Batch Records, Deviations, and CAPAs
• Ensure department compliance with quality standards, safety regulations, and OSHA requirements
• Manage deviations and CAPAs for the training and learning team

Requirements

• Minimum B.S. in biology, biochemistry, bioengineering, or a related technical field
• Minimum 5 years of experience in biopharmaceutical-based GMP manufacturing operations
• Experience in cell culture and associated downstream processing
• Demonstrated technical knowledge of aseptic processing in cleanroom environments (ISO class 5)
• Strong technical writing ability for SOPs and batch records
• Ability to work in a cleanroom environment with biohazards, human blood components, and chemicals
• Ability to lift and carry up to 45 pounds and stand/walk for 90% of the workday

Preferred Qualifications

• Minimum 2 years in a Lead, Leadership, or Supervisory role
• Experience with learning needs assessment and program design
• Familiarity with 21 CFR Part 11 and standard GxP best practices

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells.