Analytical Sciences and Technology Specialist II

Responsibilities

• Perform data trending of assay controls and compile associated metrics
• Conduct root cause analysis and investigations for audits, deviations, and OOS/OOT results
• Support investigations for analytical assays including flow cytometry, ELISA, and microbiology
• Initiate and manage change controls and Corrective and Preventive Actions (CAPA)
• Support technical development, method validation, and instrument qualification
• Perform investigational testing in the laboratory as required
• Maintain Good Documentation Practices for all records and summaries

Requirements

• Bachelor’s degree in biology, Biochemistry, Microbiology, Chemistry, or related scientific field
• Minimum of 3 years of relevant experience
• Functional knowledge of Flow Cytometry, Cell-based ELISA, and cell culture
• Proficiency in technical writing for SOPs, protocols, and test methods
• Strong detail orientation and ability to manage multiple priorities
• Proficiency with Microsoft Office applications

Preferred Qualifications

• Master’s degree with 4 years of experience
• Experience with cell therapy products

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.