Quality Control Analyst- Gene Therapy
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.
The Quality Control (QC) Analyst, Viral Vector is responsible for Viral Vector product release and stability testing in support of the site contract manufacturing business. In addition, this role will have responsibility for planning daily testing, maintaining data, and ensuring that work complies with (Good Manufacturing Practices/Good Laboratory Practices) cGMP/GLP regulations and meets all customer requirements. Performs testing to Standard Operating Procedures and Test Methods in compliance with cGMP/GLP while working in a team atmosphere.
- Performs Viral Vector product release and stability testing in support of the site contract manufacturing business according to Standard Operating Procedures and Test Methods in compliance with cGMP/GLP utilizing proper aseptic techniques (where applicable).
- Participate in QC testing of clinical and commercial grade product according to cGMPs.
- Perform cell-mediated bioassays, including infectious and physical titer, Western blot, (enzyme-linked immunosorbent assay) ELISA, (polymerase chain reaction) qPCR, (high-performance liquid chromatography) HPLC, (ultraviolet–visible spectroscopy) UV-Vis.
- Execute qualification or validation of test methods
- Prepare samples and maintain appropriate records for submission of samples to contract testing laboratories. Ship samples to contract labs.
- Communicates with subcontract labs to obtain information regarding capabilities, test timelines, and costs for testing unable to be performed in-house. Prepares sample shipments and submission paperwork for contract laboratory testing.
- May initiate and assist with (out of specification) OOS/deviation investigations.
- May write and revise Standard Operating Procedures (SOPs).
- Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies.
- Maintains compliance with all required training.
- Bachelor’s degree in Sciences, Master’s degree highly preferred.
- Advanced experience with cell-based assay testing such as physical and infectious titer, (polyacrylamide gel electrophoresis) SDS-PAGE, Western Blot, ELISA, HPLC, UV-Vis, microbiological testing
- Advanced knowledge of cGMP policies and procedures.
- Exposure to viral vector or virology is desired.
- Acquires and documents training on all laboratory general tasks and can perform assigned test methods and using associated instrumentation.
- Understanding of basic laboratory equipment and aseptic technique a plus.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Problem solves by selecting appropriate alternative from defined options.
- Ability to communicate and write effectively.
- Dependable and able to work well within a team.
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.