Sr. Specialist, Aseptic Observation Program

Role: Senior Specialist in the Aseptic Observation Program (AOP), responsible for training, observing, and evaluating aseptic practices in biologic/cell therapy manufacturing to ensure GMP compliance and contamination control. Responsibilities: conduct aseptic operation observations, document findings, provide real-time feedback, perform qualification activities, support investigations of deviations, develop and deliver training, and collaborate with QA, Manufacturing, and MSAT teams for CAPAs. Requirements: Bachelor's in life sciences (biology, biotech, microbiology, biochemistry), minimum 4 years' experience in biologics or cell therapy; strong knowledge of cGMP, GxP, 21 CFR Part 11, and aseptic processing; excellent observational and communication skills; experience with sterile injectables and electronic quality systems. Preferred: certification in aseptic processing, experience with sterile products, change management skills, and familiarity with ergonomic practices and biosafety Level 2 environments. HighValue: biologics/cell therapy, aseptic techniques, GMP compliance, biosafety, GxP, and electronic quality systems. Reporting to: Manager/Sr. Manager. Work setup: US-based, in cleanroom environments, with shift flexibility (day and evening shifts).