Quality Control Microbiology Specialist
Great opportunity to be part of a dedicated team building capability to serve the rapidly expanding gene therapy market. Vector Biomed aims to become a leading supplier of high quality Lentiviral vectors for research and clinical use. Team members will support both pre-clinical and GMP Quality Control release testing in a dynamic new company setting. We are seeking persons experienced in the Quality Control testing of biologics in a GMP setting. Experience with mammalian cell culture, Molecular Biology, Immunoassay and Assay Qualification desired.
-Establish process and documentation for EM monitoring program to support mfg
-Spec and order equipment; set up labs
-Train other internal or contract resources as needed to support routine EM
-Support execution of EM-PQ
-Serve as liaison between MFG and contract cleaning services to monitor cleaning service effectiveness, adapt to MFG schedule, etc.
-Establish and execute appropriate microbio based QC assays (TBD)
· BS and a minimum of 3 yrs relevant experience in a GMP QC role
· Experience with mammalian cell culture, excellent aseptic technique
· Comfortable working with new assays and technologies
· Experience with DNA Extraction, PCR, qPCR, ddPCR, dPCR is beneficial
· Comfortable working in general laboratory setting - pH, ELISA, PicoGreen, MBCA, HCP ELISA
· Prior experience with QC of viral vectors is beneficial
· Employee must be interested in cross-training to perform all QC assays
.Experience with sequencing analysis a plus