Lentigen - Quality Control Manager - Gaithersburg, MD

Your tasks

As a key member of the Lentigen Technology team, you will have the opportunity to lead and oversee the operations of the Quality Control department and quality initiatives. You will apply your proven expertise to manage, develop and provide leadership to employees executing analytical lot release testing, microbiology, raw material qualification and environmental monitoring support of clinical and commercial manufacturing. Furthermore, you will establish technical and compliance suitability for all testing and implement stringent and sustainable GMP lab controls to ensure practices align with regulatory expectations. Overall, your exceptional ability to provide guidance and leadership in the application of cGMP throughout the day-to-day Quality Control functions, will drive the continuing business success of Lentigen Technology as a whole.

Your profile

  • You hold a M.S. or B.S. in the life sciences
  • You possess a minimum of 3 years experience leading a team
  • You are an effective and timely cross-functional communicator  
  • You have a minimum of 5 years experience in the following:
    • Quality Control program development
    • Assay/Method Qualification
    • API, Biologics, or Sterile Drug Product
    • International regulatory inspections
    • Working in a CMO environment
    • Advanced Assay Platforms experience including; Cell Base, Flow Cytometry, qPCR and ELISA, FACs, DNA extraction, and Cell based assays
    • QbD and DOE experience is a plus 

Lentigen Technology Inc., a Miltenyi Biotec company, is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

At Lentigen, we support the development and commercialization of novel treatments for human disease through the utilization of Lentiviral Vectors. We hold this widely recognized and clinically relevant method for delivering genetic materials into cells in order to modulate their function as core strength of our company. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Gaithersburg campus we strive to find solutions to both the technical and conceptual barriers to the implementation of gene therapy approaches for the treatment of human disease.

Lentigen Technology, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

To learn more please contact:

Human Resources,
North America
+1 530 887 5304