Supervisor, Quality Control - Cell Therapy

United States, Houston (Texas)

Supervisor Quality Control, 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.

The Supervisor of QC Cell Therapy is responsible for supervision of Cell Therapy Quality Control (QC) Flow Cytometry personnel, assays and equipment in support of the production, release, and distribution of Cell Therapy products.  Works in cooperation with the Quality Assurance groups to ensure client methods are successfully executed in the QC lab for use in support of Cell Therapy Operations.     

Key responsibilities:

  • Responsible for supervision of the Cell Therapy Flow Cytometry 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.   
  • 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. 
  • Leads and mentors others with technical investigations.
  • Leads and mentors others with technical investigations.
  • Performs other duties as assigned.

Key requirements:

  • Bachelor degree in related Science field of study
  • Advanced skills and experience in Quality Control
  • Demonstrated knowledge in biological, cell based assays including flow cytometry. 
  • Experience with method validation and technology transfer preferred.
  • In-depth understanding of concepts and principles in own discipline and a basic knowledge of these elements in other areas.  Stays aware of new technologies and potential applications in area.
  • Develops training plans and performs identification and remediation of training gaps.
  • Should possess knowledge of how to execute team methods/procedures and operate equipment.  May need to support and/or execute analyst tasks on a non-routine basis
  • Develops training plans and performs identification and remediation of training gaps. 
  • Knowledge of SAP and TrackWise systems a plus.
  • Uses experience and knowledge to solve problems, make decisions or make plans for their area.  Makes recommendations for department.
  • Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
  • Improves efficiency of self and team by clearly defining and analyzing problems and implementing new ways of approaching work. 
  • Demonstrated experience in management of complex tasks and projects. 
  • Works with manager to ensure group timelines are aligned with department  goals.
  • Prioritizes work of team based on input from management and is able to clearly communicates rationale for priorities.  
  • Can clearly and confidently communicate expectations effectively to all members of their team.
  • Uses mediation skills to avoid or resolve conflict.  Is able to deliver criticism in a constructive manner. 
  • Communicates thoughts, ideas, information, and messages which may contain technical information in a logical, organized, and coherent manner.
  • Capable of leading teams and identifying appropriate path to meet team objectives.
  • In conjunction with the program management team, helps develop loyalty and trust with customers.  Able to make and deliver on promises of projects within group control.
  • Actively works to establish strong relationships within the group and with other department managers to improve harmonization and effectiveness.
  • Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence.
  • Leads by example – models good behavior, work ethic, and teamwork.
  • Champions change speaking positively to and about others in all situations.  Encourages a positive, solutions-focus attitude in all team members

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. 

Reference: R44792