Manufacturing Specialist I

Responsibilities

• Support documentation including drafting and approval of SOPs, Batch Records, Deviations, and CAPAs
• Lead investigations into nonconformances and deviations using structured root cause analysis
• Manage change controls associated with manufacturing areas and equipment
• Participate in technology transfer and technical information sharing
• Adhere to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and Good Documentation Practices (GDP)
• Troubleshoot operational issues and provide on-the-floor support
• Ensure raw data records are accurate, complete, and meet protocol specifications

Requirements

• Bachelor’s degree in biology, biochemistry, bioengineering, or a related technical field
• Minimum of 2 years of experience in biopharmaceutical GMP manufacturing operations
• Strong technical knowledge of aseptic processing in cleanroom environments
• Familiarity with LIMS/MES data and sample management
• Knowledge of 21 CFR Part 11 and standard GxP best practices
• Proficiency in Microsoft Excel, Word, and Outlook
• Ability to work in a cleanroom setting with biohazards and chemicals

About the Company

Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on TIL.