Quality Control Project Lead, Cell Therapy

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.

The Quality Control Project Lead, Cell Therapy leads the introduction of new methods and processes into the Quality Control (QC) department via the technology transfer process, represents the department on project teams, and provides technical support during investigations.   

Key responsibilities:

• Participates in the initial assessment of new products and processes.

• Provides input to program management regarding QC capabilities and requirements for method qualification/validation.  Reviews applicable regulatory guidance and internal policy documents to ensure compliance. 

• Provides technical review of Statements of Work (SOWs) to support contract manufacturing activities.

• Provides QC representation to project team meetings.  Provides routine feedback regarding tech transfer and testing status.  Supports stability program by gathering information needed to initiate protocols and tracks status of timepoint summaries.   

• Writes, reviews, and/or approves Test Records/Forms, Sampling Plans, and Specifications. 

• Leads tech transfer activities related to QC including generation of a QC master transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines

• Works in cooperation with BioAnalytical Services to design qualification, and validation protocols.     

• Assists with QC procurement, setup, and validation activities for new equipment and materials required to support new methodology. 

• Assists with responses to audits, deviations, out of specification (OOS) investigations, and corrective/preventative actions (CAPA). 

Key requirements:

• Bachelor's of Science or related field.

• 5+ years' quality control experience.

• Experience with method validation and technology transfer required.

• Knowledge of biological cell-based assays such as proliferation/cell count and viability, flow cytometry, ELISA, and PCR preferred. 

• Able to develop and deliver training programs for specialized and advanced activities. Will train trainers on how to develop effective on the job training.  

• Able to write complex procedures and reports.

• Must have previous client interfacing experience. 

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.