We are seeking a highly motivated Flow Cytometry QC Scientist to support Quality Control operations in a GMP-compliant cell therapy environment. This role is responsible for executing analytical testing to ensure the safety, identity, strength, purity, and quality of cell-based products. The primary focus will be on flow cytometry assays, with cross-training in complementary analytical methods such as ELISA, qPCR, and cell culture.Key Responsibilities:Perform flow cytometry testing to support assays including percent transduction efficiency and CD90 expression.Execute analytical test methods for in-process samples, bulk drug substance, final drug product, and raw materials for release and stability.Coordinate and schedule testing activities in alignment with manufacturing timelines.Review and maintain compliance of SOPs and analytical test procedures.Ensure accuracy and completeness of QC raw data in accordance with SOPs and regulatory standards.Troubleshoot assay performance and investigate nonconforming data.Respond to Out of Specification (OOS) results, initiate investigations, and execute CAPAs.Uphold data integrity and document work using Good Documentation Practices and ALCOA principles.Maintain laboratory cleanliness, organization, and logbook accuracy.Conduct internal audits and GEMBA walk-throughs to ensure compliance.Author and execute protocols, technical reports, and change controls.Perform equipment standardizations and qualifications as needed.Train and mentor other laboratory personnel.Collaborate with Manufacturing, Quality Assurance, and Facilities to meet operational goals.
- ID: #54526005
- State: Pennsylvania Exton 19341 Exton USA
- City: Exton
- Salary: USD TBD TBD
- Job type: Full-time
- Showed: 2025-09-19
- Deadline: 2025-11-18
- Category: Et cetera