Neogene Therapeutics is hiring a
Associate Quality Control Microbiologist

Summary

Join our Quality team at AstraZeneca's Oncology R&D division to contribute to the advancement of our product pipeline by performing environmental monitoring, lot release testing, and other assigned tasks.

Requirements

• BS or MS in biological sciences or a related field is required
• Experience in Cell or Gene Therapy
• Demonstrated knowledge of regulatory guidance and industry best practices
• Knowledge in several of the following areas of competency: aseptic processing, clean room gowning and contamination control, environmental monitoring
• Understanding of Microbiology principles, theories, concepts and laboratory methodologies
• Must demonstrate effective organizational skills and ability to manage multiple projects
• Must have demonstrated experience interpreting technical results and summarizing these results in technical reports
• Knowledge of aseptic manufacturing and EM processes

Responsibilities

• Conduct microbiological tests, including environmental monitoring, sterility testing by BACT and compendial, bioburden testing, endotoxin testing, and microbial identification
• Complete Environmental Monitoring Performance Qualification (EMPQ) protocols
• Ensure the QC microbiology laboratory is well-maintained, including equipment calibration, validation, and maintenance. Manage laboratory supplies and inventory
• Interpret microbiological data, ensuring accuracy and compliance with established standards. Maintain detailed and accurate records of all testing and results. Participate in EM excursion and out of specification (OOS) investigations
• Review QC Micro test results
• Work with multiple teams, including Manufacturing, Quality Assurance, and R&D, to support ongoing projects and ensure quality standards are met
• Perform other responsibilities as requested by supervisor/manager to support the quality team

Benefits

• Short-term incentive bonus opportunity
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage