Quality Control Project Lead

Quality Control Project Lead

Location: This is an on-site position located in Pearland, TX.

Available shift: 8:00 am to 5:00 pm Monday through Friday

The Quality Control (QC) Project Leadwill lead the introduction of new methods and processes into the Quality Control (QC) department through technology transfer, provide technical support for investigations, and act as the QC representative on project teams. This role supports method validation, ensures compliance with regulatory requirements, and contributes to the successful execution of QC testing for cell and gene therapy products.

What you will get: 

This is a competitive, salary position. In addition, below you will find a comprehensive summary of the benefits package we offer: 

• Performance-related bonus. 
• Medical, dental and vision insurance. 
• 401(k) matching plan. 
• Life insurance, as well as short-term and long-term disability insurance. 
• Employee assistance programs. 
• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do: 

• Lead tech transfer activities including development of transfer plans, protocols, and reports.  
• Provide QC representation in project team meetings and communicate project status and timelines.  
• Review regulatory guidance and internal policies to ensure compliance with cGMP standards.  
• Write, review, and approve test records, sampling plans, specifications, and QC documentation.  
• Support stability programs and track testing progress and deliverables.  
• Collaborate with cross-functional teams including QA, MSAT, and manufacturing.  
• Assist with deviations, OOS investigations, CAPAs, and audit responses.

What we are looking for:

• Experience from 3 to 5 years in Quality Control.

• Minimum of Bachelor’s degree required in a scientific discipline.

• Experience with method validation/qualification and technology transfer in a QC environment.  

• Knowledge of biological and cell-based assays such as flow cytometry, ELISA, HPLC, ddPCR, and qPCR is preferred.  

• Familiarity with cell and gene therapy products preferred.  

• Strong understanding of cGMP principles and regulatory compliance.  

• Demonstrated ability to manage complex projects and prioritize tasks effectively.  

• Strong communication skills, including writing technical procedures and presenting project updates.  

• Proven ability to collaborate, lead teams, and build cross-functional relationships.  

• Proficient in using spreadsheets, databases, and word processing software.

  

About Lonza:

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.