Quality Assurance Manager at NorthEast Bioanalytical Laboratories LLC - Hamden, CT, US
NorthEast BioAnalytical Laboratories LLC (NorthEast BioLab) has 15+ years experience delivering GLP and clinical bioanalysis services for drug testing and biomarker analysis to biotech and pharma sponsors, as well as the scientific and academic community across the healthcare sector. We are a full service, GLP/GCLP compliant, FDA audited, and DEA & CT State Schedule II-IV approved, Watson LIMS enabled facility. We have extensive expertise in method development/transfer and full assay validation on mass spectrometric and chromatographic (LC-MS, HPLC-DAD/UV, etc), Ligand Binding (ELISA, Luminex, MSD, etc), as well as qPCR platforms. In addition to pharmacokinetics (PK) sample analysis, toxicokinetic safety testing, and biomarker testing, our custom assay services include immunogenicity (ADA) assay, cell-based assay, biochemical assay, and Mechanism of Action (MoA) studies. Founded in 2003, we are a mission-driven team of veteran chemists and biologists with an excellent track record of providing rapid and high-quality assay development, preclinical, and GCLP clinical Contract Research Organization (CRO) services. One of the ways we differentiate ourselves is through our fast turnaround with high quality at competitive pricing. Thus, our experienced team would happily assist you in developing effective strategies to meet the stringent expectations and timelines associated with various milestones throughout your drug development life-cycle.Speak with our scientists today to expedite your drug development and discovery!