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Quality Control Product Development

Location:
Toms River, NJ
Posted:
February 05, 2024

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Resume:

HALIMA DIAWARA

732-***-**** ad3eez@r.postjobfree.com

SKILLS

Molecular Biology: Recombinant DNA techniques, Western Blotting, RT-qPCR, Gene Cloning, Clone analysis by PCR, Site directed mutagenesis, CDNA synthesis, Reverse transcriptase, SDS-PAGE, ELISA

Cellular Biology: Isolation of gene by PCR, Protein extraction, Protein purification, DNA Quantification, Bacterial transformation

Microscopy: Light microscopy, Fluorescent

Histology: Immunohistochemistry, H&E staining

Computational: Python, Bioinformatics, GraphPad, Java, Veeva Vault, SQL

Language: English, Bambara, Soninke, French

Statistical analysis

Product development

Process engineering

RESEARCH EXPERIENCE

Research and Development Scientist Celularity Jan 2019 - Mar 2023

Aided downstream processing advancements, ensuring alignment with stringent regulatory guidelines and industry best practices.

Designed and executed innovative process development experiments with a strong emphasis on product safety, efficacy, and translational research, bridging laboratory discoveries to potential clinical applications

Authored critical Standard Operating Procedures (SOPs) for endotoxin screening, demonstrating meticulous attention to detail and commitment to quality control and compliance.

Generated high-quality technical reports, conducted thorough data analyses, and delivered impactful presentations to internal and external stakeholders.

Managed Laboratory Information Management System (LIMS) documentation, maintaining accurate records of SOPs, work instructions, and experimental data.

Proactively initiated and implemented change requests in the Content Management System (CMS), driving continuous improvement in laboratory processes and procedures.

Led research initiatives for the development of scalable tissue scaffolds, optimizing manufacturing processes for enhanced biocompatibility and transplantation safety.

Documented key information in laboratory records, contributing valuable insights into assay protocols, quality control measures, and experimental outcomes.

Collaborated cross-functionally with external partners and Contract Research Organizations (CROs), contributing to the design, analysis, and interpretation of experimental endpoints.

Contributed to the successful development and FDA clearance of innovative medical devices, including the Connective Tissue Wrap and Placental Extracellular Matrix Osteoconductive Properties.

Bioinformatics Programmer CHOP Jan 2022 – Mar 2023

Utilized advanced bioinformatics tools and software packages to analyze genomics data, including DESeq2, fgsea, Reactome.bd, and msigdb.

Performing statistical analysis

Analyzing cancer genomics in bone diseases

Proficient in handling common genomics data formats such as FASTQ and familiar with various open-source bioinformatics platforms, including Bioconductor.

Leveraged Gene Set Enrichment Analysis (GSEA) databases to systematically evaluate the significance of genetic associations and pathways, providing valuable insights into complex biological processes.

Developed proficiency in R programming language, enabling in-depth analysis and interpretation of genetic information to establish correlations between genotype and phenotype

R&D Bio-process Characterization Intern Celularity Jun 2021 – Aug 2021

Conceptualized and executed translational research experiments aimed at comprehensive characterization of placental biomaterials, demonstrating a strong commitment to scientific innovation and advancement.

Optimized tissue decellularization methods, enhancing biocompatibility and safety profiles, and ensuring efficacy for transplantation procedures.

Applied comprehensive knowledge of ISO, GLP, and cGMP standards to ensure strict adherence to biocompatibility guidelines, contributing to the successful characterization of extracellular matrix (ECM) biomaterial products for medical applications.

Work resulted in complete characterization of an extracellular matrix (ECM) biomaterial product to ensure their safety and efficacy for use in medical applications

PROFESSIONAL EXPERIENCE

Case Investigator Project Management Ocean County Health Department Nov 2020 – May 2021

As a key member of the COVID-19 response team, leveraged scientific knowledge to collect and record comprehensive symptom information into a sophisticated database, while ensuring the accurate and timely identification of potential cases.

Maintained clear communication with team supervisors, providing critical updates and contributing to comprehensive reporting efforts.

Additionally, utilizing communication and interpersonal skills, took an active role in educating and informing individuals on symptom monitoring, quarantine, isolation, and related-concerns.

Utilized cutting-edge cloud systems, such as AWS, to access patient information and support efficient, data-driven decision-making.

Understanding of HIPAA and importance of privacy of patient data

Specimen Accessioner LabCorp Dec 2020 – Mar 2021

Proficiently cultivated and identified diverse microorganisms, ensuring streamlined workflow and timely results.

Proficiency in managing biospecimens, processing samples, and adhering to best practices in biobanking.

Conducted precise blood counts, showcasing expertise in diagnostic procedures

introduce and prepare biological specimens to the laboratory to ensure accurate processing

Open specimens and pour off into secondary containers to prepare for analysis and testing

Verify patient demographic information matches the test requisition form submitted

Data entry of patient information into the computer system for tracking purposes

Meet key production metrics and quality measures to ensure timely and accurate results

Unpack and route specimens to their respective staging areas Pack and ship specimens to proper testing Medical Device Lab Technician. Perma Pure Dec 2012 – Dec 2014

Ensured reliable operation of biomedical devices through rigorous testing and validation procedures, contributing to the enhancement of product performance and efficiency.

Engineered Nafion tubing, implementing innovative solutions to improve production processes and optimize manufacturing efficiency

EDUCATION

Master of Science: Biomedical Sciences Syracuse University Syracuse, NY Dec 2021

Bachelor of Science: Biology Temple University Philadelphia, PA Dec 2019



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