Senior Quality Control Analyst, Cell Therapy (Biotech)
Senior Quality Control Analyst, Cell Therapy
Houston, Texas, In- Office
Join Lonza AG in Houston, TX, as a Senior Quality Control Analyst in Cell Therapy. Be part of a high-reaching team developing elite health care solutions. This role focuses on driving Quality Control assays for cell therapy products, raw material release, and stability studies. Your ideas will resolve our success and impact lives globally.
Key responsibilities:
Perform Quality Control (QC) biological/cell-based testing for Cell Therapy release and stability samples, including flow cytometry based assays, proliferation, ELISA, cell counts, and immunofluorescence microscopy/spectroscopy assays.
Write and revise SOPs, Forms, and Test Records, and handle Deviations and CAPAs as required. Initiate Change Controls and complete necessary documentation.
Support Cell Therapy technology transfer activities and validation of analytical methods, including training on new methodologies, setting up new equipment, developing method SOPs, and driving validation protocols.
Initiate Out of Specification (OOS), Cell Review Committee (CRC), and deviation investigations to address lab non-conformances.
Order supplies and reagents, and perform general lab and equipment maintenance duties.
Perform other duties as assigned.
Key requirements:
Bachelor's Degree in a Scientific field.
Advanced experience in a scientific laboratory, preferably within a cGMP environment.
Demonstrated expertise in biological, cell-based assays, including flow cytometry.
Demonstrated capability to complete methods/procedures and operate equipment while closely adhering to cGMP and cGDP principles.
Knowledge of basic and specialized lab equipment and cGMP principles, with the capability to identify breaches and suggest corrective actions.
Prior experience with SAP and TrackWise is a plus.
Decision-making skills, proposing ideas during problem-solving, root cause analysis, and process improvement events.
Ability to record test results, maintain raw data, and keep accurate laboratory records.
Effective representation of the department in meetings and project teams, providing timely updates.
Reliable standout colleague who sets a positive example, providing mentorship on compliance and personal interactions.
Willingness to pursue opportunities with substantial benefits, even if risks are involved.
Champion of change, positively communicating with and about others in all situations.
Shift: Working hours are 7am - 7:30pm on a 2-2-3 shift pattern
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.
