Performs Quality Control assays for product release of cell therapy products, Raw Material Release and Stability Studies. Maintain data and follow cGMP regulations including writing deviations and other Quality documentation.  Skill set includes (but is not limited to) working knowledge of Immunofluoresence, Sample Handling and Flow Cytometry.

Key Responsibilities:

• Performs Quality Control (QC) biological/cell based testing of Cell Therapy release and stability samples. Typical test methods performed include flow cytometry based assays, but analyst may also perform proliferation, ELISA, cell counts (manual and automated), and immunoflourescence microscopy/spectroscopy assays.
• Write original and revise current SOPs, Forms and Test Records. Writes edits and approves Deviations and CAPAs as required. Responsible for initiating Change Controls and completing necessary documentation.
• Actively participates in support of Cell Therapy technology transfer activities and validation of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols.
• Initiates Out of Specification (OOS), Cell Review Committee (CRC), and deviation investigations as needed to address non-conformances in the lab.
• Orders supplies and reagents.
• Performs general lab and equipment maintenance duties.

Key Qualifications:

• Bachelors Degree in a scientific field
• 2+years of relevant experience
• In-depth knowledge of cGMP principles.  Able to identify breach of cGMP principles and provide suggested corrective actions
• Proficient in the use of spreadsheets, databases, and word processing software.
• Prior experience with SAP and TrackWise a plus
•  Uses knowledge of defined SOPs & policies to make decisions. Reviews more complex decisions with supervisor and/or other departments.
• Writing is typically free of punctuation, spelling and grammatical errors
• Records test results and maintains raw data and accurate laboratory records.
• Is able to effectively present information and ideas formally and informally to others in a manner that facilitates understanding.
• Provides suggestions for improvement to documentation and workflows.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.