• Responsible for sample preparation and running batches for bioanalytical method development (PK, ADA, biomarkers, DNA, RNA, genomics, flow), validation and sample analysis in support of preclinical and clinical drug development• Assisted in the creation, maintenance, and improvement of standardized tools for method development and validation activities • Identified opportunities for automation to increase speed and efficiency.• Collaborated with senior scientists to develop innovative bioanalytical techniques in support of contemporary therapeutic strategies discovered by Inotiv’s client base.• Performed quantitative analysis of biological samples (e.g. blood, plasma, urine, tissue, etc.) for exogenous (mainly drugs) and endogenous compounds for Biotherapeutics and Biomarker compounds• Assisted with performing method development, validation, sample analysis, resolved issues, and failures with internal and external project teams in a collaborative and supportive manner.• Identified new approaches, methodology, and/or the advent of state-of-the-art equipment

•Operated analytical instrumentation and testing with the following: X-Ray Diffractometer (XRD), Brunnett-Emmett-Teller(BET) Analyzer, Thermogravimetric Analysis (TGA), Scanning Electron Microscopy(SEM), Pycnometry, 3D Optical Profilometer, Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES)• Compiled and analyzed analytical data, identified out-of-spec sample• Collaborate, coordinate, and communicate across departments for sample scheduling, equipment utilization, and testing methods• Actively contributed to validation, calibration, Gauge R&Rs, and process optimization efforts• Assisted R&D and/or Engineering exploration work

• Performed assay qualification and validation as well as analytical testing on in process samples, drug substance and drug product for release and in support of stability studies• Performed GMP release and stability testing in Quality Control• Executed analytical testing including: SRID, BCA, A280, VaxArray, DLS, UV Spectroscopy, ELISA, SDS PAGE, Capillary Electropheresis• Became a qualified trainer/Trained new employees on testing methods• Asisted Analytical Development with method development, training, testing, etc.• Ensured that written records and work undertaken are performed in accordance with cGMP and company procedures• Participated in technology transfer, method qualification and validation• Kept accurate testing records and assured that laboratory equipment has been calibrated, standardized, and monitored as appropriate• Assisted in the writing, reviewing and editing of standard operating procedures• Participated in continuous improvement projects• Assisted in the maintenance of the lab including routine housekeeping activities…

• Performed and reported on data analysis and outcomes from Quality Control (QC) testing• Performed quality control functional testing (QC) of coated plates including all of the following: phosphoprotein/biomarker, cytokine and chemokine assays, and kit component retesting for expiration date extensions• Tested in BSL-2 designated laboratories• Performed daily data analysis and record-keeping, including evaluation of data against specifications for uniformity and component testing• Facilitated the anchoring of standards• Operated QC equipment such as the Cy-Bi and epMotion automated pipettors

• Performed analytical characterization of qualified raw material for released products (dynamic light scattering/photon correlation spectroscopy, capillary isoelectric focusing, and experion)• Executed testing of manufactured reagents (detection antibodies, read buffers, Free Tag, blockers, calibrators, and diluents)• Interpreted data and test results, and compared them to established specifications and control limits for uniformity and component testing • Performed quality control testing with 96-well and 384-well immunoassay plates, plate tops, plate bottoms and adhesives, assembled uncoated plates, and kits• Operated and tested with QC equipment such as the Cy-Bi, epMotion automated pipettors, Quickplex Imager, Sector Imager, DLS readers, and spectrophotometers • Maintained and reviewed QC logbooks, including reagent preparations (buffers, diluents, etc.)• Generated deviation/out of specification reports, change control requests and CAPAs• Prepared applicable documents, forms, and records such as analytical batch records while following Good Documentation Practices

• Prepared and disposed of test materials, vehicles, and reagents according to study protocolsand SOPs• Prepared liquid media using aseptic techniques• Prepared labels and related documentation of study procedures• Collected and documented pertinent data, including lot information, Certificate of Analysis,• and Material Safety Data Sheet• Assisted with the receipt, distribution, preparation and disposition of test compounds, reagents,• and carriers/vehicles in compliance with appropriate SOPs, GLPs, and regulatory agency• guidelines• Maintained inventory of drugs, reagents, and lab supplies• Monitored test materials and maintained facilities for cleanliness, safety, and regulatory• compliance.• Documented concerns, deviations, support resolution and appropriate corrective action, when• necessary.• Performed complex mechanical alignments and calibration of equipment to quality standards.