IBUKUN OGUNYEMI

Molecular Labs - Reviewed and updated Instructions for Use (IFUs) for reagents and IVD products - Contributed to product information and lifecycle management via SAP database - Supported post-market quality team in complaint investigation and resolution - Created and maintained training content and documents - Participated in change management - Worked in ISO 13485 environment

qPCR Assay Development - Supported the Project manager in assay development and evaluation - Reviewed test protocols, SOPs and quality assurance procedures - Trained and supervised laboratory technicians - Analyzed and validated RT-PCR data - Inventory of laboratory consumables

Clinical Lab Operations - Performed quality control for RT-PCR runs processed by the lab - Quantitatively analyzed of SARS-CoV2 RT-PCR data - Communicated analyzed results to the medical team

Quantitative RT-PCR detection of the coronavirus SARS-CoV-2. - RNA extraction - Prepared master-mix - Quantified RT-PCR assay result

- Co-reviewed CTDs and registration documents to ensure regulatory compliance - Participated in GMP and quality management audit of biopharmaceuticals and medical device factories to monitor compliance with quality standards - Documented and evaluated of product failure and monitored product recall - Processed ADR reports to the National Pharmacovigilance Center

Qualitative and quantitative test method for the detection of wheat bunt disease (Tilletia spp.) by means of qPCR assays - Spore pellet preparation from wheat seed lots - DNA isolation from wheat spore pellets - qPCR quantification

Chromosome Conformation Capture in Cow Liver - DNA extraction and quantification - Preparation of 3C libraries - qPCR test for primer efficiency - PCR amplification