Senior Analyst - Cell Therapy, Quality Control
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
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
- 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.
- Performs other duties as assigned.
- Bachelor Degree in Scientific discipline
- Advanced experience in scientific laboratory
- Advanced experience in cGMP environment
- Demonstrated knowledge in biological, cell based assays including flow cytometry.
- Possess knowledge of how to execute methods/procedures and operate equipment.
- Perform tasks with strict adherence to cGMP and cGDP principles.
- Knowledge of basic and specialized lab equipment.
- In-depth knowledge of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions.
- Considered Subject Matter Expert on routine and select specialized methods
- Prior experience with SAP and TrackWise a plusDecision Making
- Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows.
- Records test results and maintains raw data and accurate laboratory records.
- Capable of effectively representing the department in meetings and on project teams. Provides timely, clear, and accurate updates without being prompted.
- Dependable and able to work well within a team.
- Leads by example and offers guidance to co-workers with respect to compliance and personal interactions.
- Actively attempts to understand the logic or basis for change in tasks or situations. Able to identify trends in testing.
- Is considered a go-to person for assistance.
- Willing to pursue opportunities that can lead to substantial benefit, even if there are risks involved.
- Champions change speaking positively to and about others in all situations
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.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.