Quality Control Analyst II, Cell Therapy (PM Shift)

PM Shift (7:30 PM - 7:30 AM)

Today, Lonza is a global leader in life sciences operating across five 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.

Join Lonza AG as a Quality Control Analyst in Houston, TX, where you will play a pivotal role in our continued growth and success. Our ambition is to maintain our world-class standards and drive outstanding results. This role is integral to our cell therapy production, ensuring flawless execution and delivering high-quality outcomes.

Key responsibilities:

• Work the PM shift (7:30 PM - 7:30 AM) to ensure continuous quality control support.

• Apply various methods like flow cytometry, ELISA, and cell counts to perform Quality Control (QC) biological/cell-based testing on Cell Therapy samples at different stages.

• Develop, modify, and sustain Standard Operating Procedures (SOPs), Forms, and Test Records.

• Author, edit, and approve Deviations and Corrective and Preventive Actions (CAPAs) as required.

• Initiate and detail Change Controls to ensure compliance and continuous improvement.

• Actively support Cell Therapy technology transfer activities, including the validation and qualification of analytical methods. This involves training on new methodologies, setting up new equipment, developing SOPs, and performing validation/qualification protocols.

• Initiate Out of Specification (OOS) and deviation investigations to address non-conformances in the laboratory.

• Manage the ordering of supplies and reagents to ensure laboratory operations are uninterrupted.

• Conduct general laboratory and equipment maintenance duties.

• Perform additional tasks as assigned to support the team and company goals.

Key requirements:

• Bachelor of Science degree in a related field with advanced knowledge in relevant areas.

• Proven expertise in biological, cell-based assays including flow cytometry.

• Experience in completing methods/procedures and operating specialized lab equipment.

• Ability to perform tasks with strict adherence to current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).

• Proficiency with basic and specialized laboratory equipment.

• Skilled in using spreadsheets, databases, and word processing software.

• Prior experience with SAP and TrackWise is advantageous.

• Capable of making decisions based on defined SOPs and policies, while knowing when to consult supervisors or other departments for more complex decisions.

Come join our team in the life sciences field, where your contributions are

valued and your professional growth is supported. Together, we can achieve outstanding results and positively impact millions of lives.

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.