Quality Control Manager, Cell 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.

Lonza is building a large scale dedicated facility to allogenic product for a key customer.

This position is responsible for management of the large scale allogenic manufacturing Quality Control (QC) laboratory.

This laboratory is expected to perform Cell Biology, Biochemistry, and Safety assays in support of the production, release, and distribution of Cell Therapy products.

During the construction phase of QC labs, the QC Manager is expected to work in close collaboration with Global Engineering team to develop QC lab design, instrument requirements and develop associated workflows.

The QC Manager works in close 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 the Operations.     

Key Responsibilities:


* 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.  


* Collaborates with QC Technical Services group, Bio Analytical Services team, MSAT, and program management to drive technical transfer, staff training, and assay qualification/validation activities. 


* 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.   


* Writes, reviews, and/or approves SOPs, sampling plans, protocols, and specifications. 


* 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 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, effic...