Manager, Quality Control - Cell Therapy
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
Lonza in Pearland (Houston), TX has an exceptional opportunity in Quality Control! The Manager of Quality Control – Cell Therapy will be responsible for management of the Quality Control (QC) Cell Therapy laboratory and for performing Cell Biology, Biochemistry, and Safety assays in support of the production, release, and distribution of Cell Therapy products. You will work in cooperation with the Technical Services and Bio Analytical Services groups to ensure client methods are adequately qualified/validated and successfully transferred into the QC lab for use in support of Cell Therapy Operations.
Responsible for supervision of the Cell Therapy lab. Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems. Reviews testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles.
Develops and maintains a tool for monitoring QC resource capacity. Provides feedback to QC management and production planners when capacity constraints exist.
Leads, mentors, and coaches staff through routine one-on-one meetings, team meetings, and effective performance management. Sets and delivers on individual and team goals that support the department and site strategy. Takes personal accountability for both his/her own and the team’s actions.
Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA). Actively works to ensure responses are completed on-time. Escalates roadblocks to completion and provides potential solutions.
Prepares project plans, writes status reports, and gives oral presentations to customers and management.
Prepares monthly management reports including budget analysis and project updates. Actively monitors spending for area. Predicts and escalates potential spending variances. Identifies corrective actions for spending variances.
Develops and monitors team performance measures to understand effectiveness, efficiency, and quality of group performance.
Bachelor's degree in a scientific discipline and relevant experience in a related field.
Advanced knowledge working in a cGMP environment.
Strong leadership experience.
Demonstrated knowledge in biological, cell based assays including flow cytometry and PCR (polymerase chain reaction) .
Experience with method validation and technology transfer preferred.
Knowledge of SAP, TrackWise, and LIMS systems a plus.
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.