Quality Control Lead, Gene Therapy (2nd Shift)

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.

Our state-of-the-art facility in the Houston area specializes in the production of cell and gene therapies. In the biopharmaceutical industry there is an increasing demand for development and manufacturing of these novel drugs. In response, we opened our 300,000-square-foot facility, fully dedicated to cell and gene therapy development and manufacturing, and the only site in our network where viral vectors are manufactured.

The Quality Control (QC) Gene Therapy Lead performs routine or specialized testing as needed to support manufacture, release, and stability testing of Viral Vector products.  This role also assists with execution of general lab support activities and provides support to the department manager with scheduling of routine tasks in the lab.

Key responsibilities:

  • Performs cell culture, molecular biology, and Polymerase chain reaction (PCR) based testing in support of manufacture, release, and stability testing of Viral Vector products. 
  • Reports test results and maintains raw data and accurate laboratory records.
  • Drafts, edits, and revises documents, including but not limited to, protocols, Standard Operating Procedures (SOP’s), sampling plans, Certification of Authenticity (CoA) templates, and product or material specifications.
  • Drafts, edits, and reviews Out of Specification and Deviation Investigations

Key requirements:

  • Bachelor’s Degree in Related Field.  Advanced degree is preferred.  
  • Experience performing cell culture, molecular biology (Western Blot, ELISA), and PCR based methods in a Quality Control setting required. 
  • Working knowledge of cGMP policies and procedures required.    
  • Knowledge of SAP and TrackWise systems a plus.
  • Demonstrated experience in management of complex tasks and projects. 
  • Able to communicate status, needs, forecasts, risks and timelines effectively to management.
  • Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence
  • 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: R22526