Performs a wide variety of experimental tasks in the laboratory.Contributes detailed observations and to keeping accurate, high-quality records of experiments. Adheres to EHS and laboratory requirements.

Independent method development and qualification of ELISA based impurity assays such as detection of host cell proteins to support drug substance and drug product release and stability testing.Plan, prioritize and execute simple and complex experiments with relevant controls. Compile, analyze, and interpret data. Ensure timely completion and delivery of analytical results and documentation for GMP and non-GMP samples (data packets, ELN, technical reports, SOPs, etc.).Helps facilitate equipment maintenance by performing regular scheduled activities to comply with GMP standards. Assited in maintaining a GMP compliant laboratory. Wrote simple technical reports & SOPs, including clear and concise technical data presentation and discussion. Presented PPT presentations on technical aspects internally.

Participates in the ELISA kit manufacturing process inside of a laboratory, making kits from the ground up starting with blank 96 wells plates. — Determining kit lot size, amount of coating buffer and antibody needed for 3-5 ug coating (avg) depending on kit type . — Plate blocking , Plate drying followed by plate packaging and sealing. — lastly plates are kit packed after reagent preparation — Participates in reagent preparation using SOP as guide to manufacture reagent solutions to correct pH and kit pack size.— Involved in preparation of Standards for ELISA plates using kit pack size , standards and control protein concentration w/ dilution factor formula (SOP) in determining amount necessary for correct reagent bulk concentration. Verifies reagent concentration using spectrophotometer and prints out data accordingly to be sent with batch record.— Dispenses reagents in BSL2 safety cabinet in appropriate bottles and using correct caps, label reagents of different volumes (200 uL, 20 mL ) in various amounts dictated by batch record — Has engaged in running ELISA assay using SoftMax software 7.1 in 2 point straight line parameter or 4 point (still somewhat new method) sigmoid curve parameter to determine quantitive analyses or amount of antibody concentration on plate rows — Inspects antibody concentrations per row and looks for correct reagent serial dilutions concentration ex 0.2data well plates re ported by software— analyze data points of linearity report or Optical density readings technician (myself) is looking for an R2 of at least 0.990 and a background under 0.150 I can always use more practice — Uses good manufacturing and laboratory practices to accomplish daily workflow intermediate computer skills . — ISO9001:2015 compliant.— Good documentation practices - SAP inventory management software novice