Lentigen - Quality Assurance & Compliance - Gaithersburg, MD

Your tasks

As a member of the Lentigen Technology team, you will have the unique opportunity to manage and control the Quality Compliance Program and support activities to ensure compliance with applicable regulations and good manufacturing practices. Furthermore, you will be responsible for reviewing, approval and management of GMP compliance systems including Quality Events/CAPA program, supplier quality program, internal and external audits, and other objective reviews of GMP data/trends. Overall, your ability to serve as subject matter expert on Quality Management Systems will help power Lentigen Technology’s continued success.

Your profile

  • You hold a M.S. or B.S. in the life sciences
  • You have a minimum of 5 years experience with the following:
    • Quality Compliance Program development and management
    • Experience as a GMP auditor
    • International regulatory inspection management
    • Experience in API, Biologics and/or Sterile Drug Products
    • Experience in a CMO environment
  • Certifications related to Auditing such as ASQ’s CQA is a plus
  • You possess a solid level of computer savvy, especially with Microsoft Word, Access, Excel, and Quality Systems Software such as MasterControl, Tackwise and SAP
  • You are an effective and timely cross-functional communicator 

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