Jerrin Gause Email & Phone Number

United States

Performed Cell Based Assays (ELISA, ADCC, etc.) and processes (cryopreservation and culturing) for GMP stability testing.Carried out QC (qPCR, HPLC, UPLC, ELISA, p.H, clarity, appearance, et.) testing for manufacturing Release and In-Process Batches. Produced Certificate of Analysis and Testing (CoA and CoT) to summarize data and meet client deadlines and expectations. Reviewed data associated with test sample planning (Batch Records, Batch Disposition) to support internal manufacturing operations per GMP standards. Support and implemented Method Qualification, Transfer, and Validations for QC and cell-based Analytical Test Methods.Function as the SME (Subject Matter Expert) for audit support/readiness regarding QC plate based assays and Cell culture operations.Certified Qualified Trainer (QT) for plate based assays and maintaining compliance for new hires and team members.Initiated, supported, and written Technical Documents, Deviations, Root Cause, Change Controls, CAPAS, Effectiveness Checks, and Laboratory Investigation Reports for the Quality Department. Good understanding of cGMP, ALCOA, ICH, CFR, quality standards, LIMS, good documentation practices, and federal regulations.

Work primarily focuses on In Vitro 3D Cultures (Organoids) for oncology clinical samples. Performed diagnostic and clinical testing on cancer samples provided through Duke University.Led and managed a team of Research Associates to assign work tasks, complete projects for CLIA Validation, data review, and updating Standard Operating Procedures (SOPs).Quantitatively measured cancer drug-dosing response rate using cell culture assays (Cell Titer Glo) for the production of IC50 curves. Performed Biobanking (Cryopreservation), passaging, and thawing of organoids for clinical experiments.Coordinated with Process Development for implementing new laboratory technologies to optimize clinical processing. Coordinated with Research and Development team for developing and testing new Standard Operating Procedures for clinical processing and R&D projects. Prepared clinical samples for Histology and DNA sequencing.Worked with manager to incorporate and improve clinical Bioassays.Used management systems such as JIRA and Smartsheet to keep track of projects and day-to-day activities.

Downstream Processing of Adeno Associated Virus included Centrifugation, Iodixanol, Cesium Chloride Gradients, and Dialysis for final product recovery.Used FPLC (Affinity, Anion Exchange, Scouting) to purify product for large and small scale production. Prepared and packaged affinity columns for large scale projects.Filtered samples using Tangential Flow Filtration and Depth Filtration.Trained new Research Associates and Scientists on all Downstream operations.Preformed data analysis and review of downstream documents submitted by the Manufacturing team.Presented chromatographs and related data to team on a weekly basis.Upstream Processing of Adeno Associated Virus included cultivating and harvesting HEK293 cells in shake flasks for small scale production.Techniques included cell counting using a CEDEX, subculturing, cell transfection (Baculovirus, Triton lysis), and re-feeding.Isolated cell pellets and supernatants for downstream processing.

Worked focused on downstream processing of clinical liver samples obtained from regional/local hospitals and clinics.Isolated and processed clinical samples to produce Hepatocytes for Biopharmaceutical companies and partners.Carried out and performed testing using cell culturing techniques generated from Hepatocytes.Prepared and evaluated Histology tissue specimens to examine the conditions of each clinical sample.Performed Drug Screening, Enzyme Profiling, and RNA testing to measure protein activity in clinical samples.Interacted and communicated with Organ Procurement Organizations (OPO) to evaluate primary liver conditions and specs prior to processing.Developed, updated, and peer-reviewed Standard Operating Procedures (SOPs).Produced and peer-reviewed reports and created Certificate of Analysis (CoA) for products.Provided and created budgets, production cost, and market trend analysis to Supervisor. Ensured proper documentation and confidentiality of donor records in accordance of HIPPA and GLP.

Rtp, North Carolina

As a Toxicology Research Associate at EPA within the division of NHEERL/ISTD/ITFB I cultivated mammalian cell cultures to study the toxicological effects of industrial chemicals. In addition, I cultivate Human Primary cells from donors in a clinical research setting based on GCP guidelines. Levels of toxicity were examined using Cell Titer Glo and Lactate Dehydrogenase (LDH) assays. RNA tissue samples were collected from exposed cells for whole Transcriptome analysis. My duties included managing a cell culture lab, keeping record logs/notes in accordance to EPA Quality Assurance guidelines, and meeting with my supervisor to discuss projects, budgets, EPA regulations, and deadlines.

Raleigh-Durham, North Carolina Area

My research focuses on studying protein receptor kinases (PRK) involved in the formation of pollen tubes in plants. My duties included purifying the PRKs from plants, specifically PRK6, utilizing Size Exclusion and Affinity Chromatography. I also had to use wet chemistry to create buffers for protein elution. I conducted Molecular Cloning techniques in order to create recombinant DNA. Finally, cell cultures were implemented to express the protein of interest using a Baculovirus at BSL-2 conditions.

Raleigh-Durham, North Carolina Area

My focus in this laboratory was to prepare Mammalian cell cultures for upstream and downstream processing. I maintained an aseptic environment within the laboratory and Biological Safety Cabinets and followed protocol according to Good Manufacturing Practices (GMP). Parts of my duties as a technician was to create a subculture, prepare nutrients and serum for the cells, understand thaw/freezing cycles, operate bioreactors, and check for cell confluency and pH changes.

Kannapolis, Nc

My internship focused on understanding the Glyceollin Pathway for Soybean crops in response to potential pathogens. The Soybean Cyst Nematode (SCN), the pathogen of study, causes an annual lost of one billion dollars in crop damage. Considering that Soybean is the 3rd largest crop and provides the necessary amino acids for vegetarians and developing countries, the SCN is a major global issue. Some research studies have shown that Soybean have health benefits and may assist humans against hormone-related cancers. The Glyceollin Pathway is a defense mechanism utilized by the many legume crops to fight deadly toxins and pathogens. Plants produce a compound known as Glyceollin, a phytoalexin and secondary metabolite, that will destroy the SCN. However, new SCN have developed a rapid evolutionary change that has allowed the pathogen to be less susceptible to Glyceollins. Furthermore, the Soybeans have limited resistant resources and is not able to defend against the nematode like it used to.Within the Glyceollin Pathway, four gene families play an essential role in the production of Glyceollin: PAL, CHS, IFS, and IFR. These genes were studied in this experiment and the gene expression of each gene family was measured with inoculation of SCN after a certain number of days. A PCR was carried out using the appropriate primer sequences gathered from NCBI. RNA was extracted from the soybean roots frozen in liquid nitrogen. The RNA also served as a template for the creation of copy DNA (cDNA) and both sets of genetic material were quantified. A qRT-PCR procedure was utilized in order to measure the gene expression of the cDNA. Finally a heat map was created using Python and Pearl programming to provide a graphical representation of the gene expression of each of the gene families. There are pictures included that show my group's poster and power point that were used at the P2EP symposium.

Raleigh-Durham, North Carolina Area

My duty is to lead lectures, discussions, and group activities to a classroom containing beginning Life Science students at NC State. As a Class Assistant, I have to to prepare workshops pertaining to topics such as time management to students who may have not developed such a skill. In addition, I grade assignments that the students turn in and also provide feedback. More importantly, I help students decide what major(s) they would like to fulfill and try to help them develop a sense of purpose for their career goals.

Raleigh-Durham, North Carolina Area

The main focus of my previous undergraduate research was to understand viral infections in plants. Gemini-viruses, which are viruses that damage plants and lead to crop damage, were one of the main subjects of the research. A model plant organism, Arabidopsis, was used in order to determine how viruses interact with the plant's cell cycle. The main purpose of this research was to determine how Gemini-viruses and plants interact at the molecular level. For an example, it was discovered that interaction between the viruses and the SUMO-conjugating enzyme must occur in order for an infection to manifest. Techniques such as Gel electrophoresis was used to determine whether plant samples contained the viruses while X-ray crystallography was used to examine the structure of infected plants.

Greensboro/Winston-Salem, North Carolina Area

As part of SIP, I operated as a tutor and assisted college students in General Biology and Chemistry. SIP tutors had to attend classes that they were tutoring and prepare activities that would reinforce the concepts learned in class to students. As an SIP tutor, you interacted with the professor in order to ensure that the material that was being covered in tutoring matched what was going on in class. In order to be a tutor, a B+ or higher must have been attained in the class.

Bachelor’S Degree, Biochemistry, Minor In Biotechnology, Senior

Activities and Societies: Biochemistry Club, International Society for Pharmaceutical Engineering I have been involved in undergraduate.

Bachelor’S Degree, Biochemistry