Lentigen - Assay Transfer & Qualification Scientist
Are you a Scientist who would thrive in an environment transferring assays from R&D to a GMP QC laboratory? Do you desire a quality role where you can utilize your assay and qualification expertise? If so, come and join our team as an…
Assay Transfer & Qualification Scientist
As a member of the Lentigen Technology team, you will have the opportunity to drive Quality Control activities associated with biological and molecular assay transfer and qualification. You will assist researchers in the initial design of assays. You will then further develop the assay using ICH guidelines as your standards. You will lead the assay transfer from R&D to GMP. You will have a active role in assay qualification and trending program for GMP lot release of lentiviral vectors and stability plans for critical reagents and critical standards. Assay development tasks will include identifying appropriate controls, standards and criteria for a valid assay, while qualification tasks will include writing, executing, and reporting qualification activities. Overall, your exceptional skills, assay knowledge, and understanding of quality control will directly bring about the success of Lentigen Technology.
- You hold a M.S. or PhD in the life sciences or a similar area of study
- You have 2-5 years of related experience and/or training in biological and molecular assay methodology
- You have experience with, but not limited to, plate readers, qPCR instrumentation, flow cytometry and cell based assays
- You have strong knowledge of quality compliance (GMP, ICH, FDA, EP, and USP policies/guidelines)
- You have a thorough understanding of analytical bio-assays, including assay transfer qualification, validation,maintenance, and statistics
- You possess a solid level of computer savvy, especially with Microsoft Word, Excel, and PowerPoint
- You are an effective and timely cross-functional communicator, self-motivated and self-starter
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.
Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability