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Assistant Ii Research

Location:
Wallingford, CT
Posted:
August 19, 2024

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Resume:

Wallingford, CT ***** 860-***-**** ***********.**@*****.***

FATEMEH FAZLHASHEMI

Wallingford, CT 06492

860-***-****

***********.**@*****.***

LinkedIn Profile: https://www.linkedin.com/in/fatemeh-fazlhashemi-b1977577 S UMMARY

Experienced research professional with demonstrated multidisciplinary history of working in the biological industry, nano-biotechnology, oncology, immunology, and clinical genomic medicine workflows. Skilled in molecular biology, immunoassay systems and immunotherapy. P ROFESSIONAL E X P E R I E NCES

Senior Research Associate

Modifi-Bio

February 2023 – May 2024

• Successfully ran 5 and 10-days GDA assays for all assigned compounds efficiently and reproducibly which resulted in an EPIC success for company’s development.

• Successfully ran CSA assays for all assigned compounds achieving the best results which was critical for the company to move forward.

• Developed protocols for the GDA, CSA assays and generated new protocols for fixing and staining the GDA plates using Thermofisher Combi.

• Successfully took responsibility and accomplished lab establishment and running/maintaining the instruments, lab inventory and weekly lab inspections.

• Trained new employees/co-workers with all details needed to every aspect of lab work from running the assays to using the instruments.

• Established data processing devices (Imaging Microplate Reader BioTek Cytation 5 – Agilent).

• Performed data analysis using Prism and CDD Vault (Scientific Data Management System and ELN Software)

Research Associate

Bio-Techne, ProteinSimple

February 2021 – December 2022

• Resolved numerous customer complaints by performing Assay testing for Product Support.

• Analyzed data, prepared summary reports and data packets for cross-functional presentations.

• Planned project assignments and prioritized based on timelines, stakeholders, complexity of the specific project and resources/reagent material availability.

• Performed immunoassay testing from single analyte/multiplex assays to custom panels. This testing was for customers protein analysis, assay complaints, internal company projects. Tests included: specificity (cross-reactivity and interference), lot-to-lot variability, recovery of spiked samples, instrument bias, antibody/reagents lot-to-lot equivalencies including new lot of monoclonal/polyclonal detect/capture antibodies (same biotinylated- new conjugation- different goat/bleed/purification), assay’s intra/inter cartridge precision, sample precision, sample values, natural linearity, spiked linearity/recovery, recombinant/natural controls, standard curves, detect/capture biotin titer, detect/capture/dye and diluents testing, and antibody stability.

• Generated new specifications as required for product sheets/inserts based on test results. 71 Terrace Gardens, Wallingford, CT 06492 860-***-**** ***********.**@*****.***

• Trained FAS (Field Application Scientists), new employees, interns for Product Support group. This training included running assays, utilizing company equipment (Ellas and Simple Plex cartridges), knowledge of safety and company rules and policies to follow SOPs and guidelines in compliance with all company safety, quality, procedures and regulations.

• Assisted Engineering and Product Support teams with validation of equipment and test methods for continuous improvement of established SOPs and creating work instructions.

• Lab coordinator for the Product Support Team, organized lab, monitored supplies for replenishment and submitted purchase order requisitions.

• Team leader in relocating Bio-Techne Product Support Lab into a new facility. Relocation included the movement of lab supplies, refrigerators, lab equipment and workstations. Performed revalidation of Product Support SOPs upon completion. Relocation required cross functional planning and collaboration.

• Utilized LIMS (Laboratory Information Management System) for sample/reagents information, tracking data, workflows, QA/QC Assays.

Virology Accessioning Supervisor

The Jackson Laboratory- JAX Genomic Medicine

August 2020 – November 2020

• Oversaw daily operations of the accession technologists including but not limited to sample receiving, sample unboxing, sample accession, sample de-swabbing and sample storage for COVID19 testing in the clinical genomics laboratory.

• Ensured sample accessioning is performed in an accurate manner to enable effective testing of samples downstream as ordered.

• Ensured sample information is correctly entered in our client's LIMS system.

• Ensured sample accessioning is performed in an accurate manner to enable effective testing of samples.

• Developed process control and QA/QC measures.

• Ensured personnel follow prescribed SOP's and practices to ensure compliance with CLIA/CAP certification.

• Provided daily laboratory update reports to Clinical Laboratory Director to improve performance by systematically removing waste and reducing variation to streamline the laboratory.

• Weekly reports on laboratory critical values to assist in noticing trends for remediation.

• Successfully sustained CLIA/CAP certification, including competency and proficiency assessments, training and safety, HIPPA and CITI.

• Assisted in training of accession technologists.

• Directly overseeing efficiency, documentation, SOP’s, and general laboratory activity.

• Developed and managed daily schedule to ensure optimal efficiency.

• Worked in a fast-paced clinical laboratory with high sample throughput and maintaining quality and TAT.

Clinical Genomic Technologist II

The Jackson Laboratory- JAX Genomic Medicine

July 2020 – August 2020

• Processed and generated data for COVID19 testing in the clinical genomics laboratory with the supervisor and manager to maintain all documentation required for operation under CLIA/CAP certification, including review and writing of SOPs as necessary.

• Used sample tracking systems in accordance with standard operating procedures. 71 Terrace Gardens, Wallingford, CT 06492 860-***-**** ***********.**@*****.***

• Completed timely completion of training assigned by management or CLD to meet the needs of laboratory operations. Participated in continuous process improvements and ongoing training.

• Ensured sample accessioning was performed in accurate manner to enable effective testing of samples downstream as ordered.

• Sample processing including nucleic acid purification and other clinical processes.

• Performed quality control of processed samples and generated data prior to sending to next steps.

• Performed accurate and timely maintenance of operational metrics.

• Maintained and updated associated process documentation. Research Associate

CaroGen Corporation, UConn Health, Farmington, CT

October 2017 – March 2020

• Conceptualized and spearheaded a Nano-delivery system to boost the immunogenicity of therapeutic VLV vaccines for chronic hepatitis B.

• Produced virus-like vesicles (VLV) cancer vaccines at large scale for in vivo assessment of immunogenicity and efficacy of vaccines for immunotherapy of chronic hepatitis B and colon cancer.

• Optimized conditions for VLV production in serum-free media to streamline the purification process and improve VLV product quality.

• Optimized the company's VLV production for efficiency and titration leading to significant cost savings.

• Assisted other team members in conducting mice immunogenicity and efficacy studies, performed dosing injections by viral vector, western blot, ELISA, FACS antibody staining, flow cytometry, collecting and harvesting spleens, lymphocyte culture, and live animal work of mice assessment up to 20 naïve mice of each experiment in BSL-2 environment.

• Validated antigen expression from VLV vaccine candidates.

• Systematically monitored temperature, cell viability, cell density, pH, and other parameters of each experiment from cell culture samples to ensure quality.

• Prepared cell samples for flow cytometry analysis and operation of flow cytometry.

• Prepared chemical solutions, media, reagents, stains, buffers and operation of laboratory equipment such as centrifuges, microscopes, incubators, autoclaves and plate readers.

• Managed timelines and deliverables and developed reports for various projects and coordinated parallel tasks across multiple projects, demonstrating prioritization.

• Trained in laboratory safety regulation and UConn Health Initial Animal User Training.

• Ensured that mice rooms are observed on daily basis to monitor for sick, impaired or dead mice and reported to manager.

• Assisted with the collection and processing of biological samples.

• Prepared and reviewed documentation and performed quality control review of study data.

• Performed all tasks in compliance with Good Laboratory Practice Regulations (GLPs), Standard Operating Procedures (SOPs), and company policies and Procedures. S K I L L S :

• ELISA, Western Blot, PCR, mammalian cell culture and aseptic techniques, luminescence- and/or fluorescence-based assays

• Aseptic cell culture (BSL2) and virus propagation using BHK-21 cells and Human Cancer Cell lines, Scaling up and cell banking for long-term storage

• Isolation of transfection-grade plasmid DNA (MAXI preps)

• Transfection

• Virus titration by plaque assay

• Protein gel electrophoresis and immunoblotting

• Bacteria staining

71 Terrace Gardens, Wallingford, CT 06492 860-***-**** ***********.**@*****.***

• Live animal work BSL-2 (mice), handle and restrain weigh mice, ear tagging, administer injections (IV, IP, IM, SC), anesthetize, maintain and evaluate mice records, prepare for sterile surgical procedures, tissue culture

• Ability to work in BSL2 and BSL3 environment, Ability to perform in a GMP and GLP environment, Knowledge of QSR and ISO

• Familiarity with biohazardous material handling and chemical safety procedures

• Sample preparation, laboratory documentation, library development, data analysis, bioinformatics, collaboration with external investigators

• Analysis of FTIR spectra, XRD data, SEM & TEM micrographs

• Synthesis of Nanomaterials- Sonochemistry

• Eager to move projects forward and optimize workflows

• Evaluate data, make observations, troubleshoot, and keep detailed records in laboratory notebook

• Ability to effectively work in a team environment

• Strong analytical, problem solving and decision-making capabilities

• Quick learner and willingness to learn new skills and technologies

• Experienced with Microsoft Office suite (Word, Excel, PowerPoint) O T HER E X P E R I E NCES

Research Assistant

University of Mazandaran (UMZ), Nano-Electronic Lab., Babolsar September 2014 - August 2015

Synthesis and Magnetic characterization of Hematite (α-Fe2O3), Maghemite (γ-Fe2O3) and Magnetite (Fe3O4) Nanostructures of Iron Oxide using sonochemistry in medical applications

(cancer diagnosis, drug delivery and treatment).

Research Assistant

University of Maragheh, Nano-Chemistry Lab. Maragheh January 2013 - December 2013

Synthesis and Application of Metal Organic Frameworks (MOFs) for biomedical imaging using combined ultrasound/nanoreactor systems.

E DUCATION

M.Sc. Material Science & Engineering (major in Nanomaterials-Nanotechnology) October 2012 - May 2014

University of Maragheh, Maragheh, Iran

GPA: 17.57/20 (First defended novel thesis, A+ + - First graduated student - Top 1% - Considered an honors student)

Thesis: Synthesis of Nanofluorapatite Using Ultrasonic Waves B.Sc. Computer Science

October 2005 - July 2009

Payame Noor University (PNU), Mazandaran, Iran

GPA: 15.18/20 (Top 3%)

71 Terrace Gardens, Wallingford, CT 06492 860-***-**** ***********.**@*****.*** P A T E N T AND AWARDS

Patent

Sonochemical Fluorapatite Nanopowder- #87635 - 01/05/2016 - International classification: B82Y;B82B;C08B -State Organization for Registration of Deeds and Properties, Intellectual Property Center, Patents, Iran. An industrial method and system to produce Fluorapatite Nanopowder

(Bioceramic) for orthopedic and dental applications. Awards

Iran Nanotechnology Initiative Council (INIC) grant for M.S. proposal, 2013 Iran Nanotechnology Initiative Council (INIC) grant for M.S. thesis, 2014 Iran Nanotechnology Initiative Council (INIC) grant for patent, 2016 USA, InnoCentive Challenge #9934125 - Oral Vaccination of Enveloped Viruses, March 2019



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