Shawn Turner

About Shawn Turner

Experienced, Molecular Biologist and business management professional (MBA) with over 25 years experience in the medical device industry bringing diagnostic products to market in both national and international clinical markets. Career experience includes Research and Development, Quality Control/Stability in a GMP environment, Next Generation Sequencing (NGS), Bioinformatics, and Manufacturing and Technical Support (MTS). Experience in SAS JMP, Python, R, UNIX/Linux and Bash scripting. Experience with pipeline development tools including SAMtools, VCFtools, BCFtools, GATK, and variant calling analysis tools. Manipulation of FASTA, FASTQ, SAM/BAM, and VCF files. Extensive Laboratory and Quality experience in a regulated environment with a demonstrated ability to achieve company goals.

Experience

1. Associate Scientist- Manufacturing and Technical Support (Mts)

   Invivoscribe

   Nov 2020 — Present · San Diego, CA, US

   Investigate IVS product performance issues through experimental studies, identify root causes and develop and verify effective solutionsResponsibilities include product development, process development and process improvement for the Invivoscribe product lines including troubleshooting activities when required by the manufacturing department, process improvements of existing products, validation of new processes and transfers of products from R&D to Manufacturing.Completing IVS Quality CAPA Impact Technical Assessments and investigating Change Notifications from vendors.Conducting Investigations of products for Customer Complaints and Nonconformance\'sPerform Post Marketing Surveillance Literature searches for Regulatory DepartmentWork with QA and Manufacturing to resolve CAPAs and NCMRs Writing Plasmid RNA Stability Study protocol for IVS DNA and RNA controls.Development of KMT2A Gene Fusion dPCR assay, completed RNA Input Study, Carryover/Crossover, Spec Setting validation studiesDevelopment of MyMRD Myeloid gene panel assay to aid in clinical decision making for treatment of Myeloma. The gene panel assay is used to identify mutations within hotspots from 53 genes for sequencing on Illuminas NovaSeq instrument.DNA Library prep using Twist Mechanical Fragmentation and Twist Enzymatic Fragmentation DNA Library Preparation Kits for Next Generation Sequencing (NGS) on Illumina NovaSeq platform.Fragment analysis- Agilent Bioanalyzer, LabChip GX Touch Nucleic Acid Analyzer, ABI 3500 CE, TapeStation DNA quantitation and sizingWrite SOP for the MyMRD Myeloid Assay protocol and assisted in preparing the Assay Workbook Validation protocolExcel Programming and Development of Assay Workbook to provide automated data analysis for use by operators when running the MyMRD Myeloid gene panel assay.DNA quantitation using QubitData analysis using SAS JMP and Illumina Sequencing Analysis Viewer (SAV).Attain quotes from external vendors for ordering

Education

• San Diego State University

  Bachelor’s Degree, Biology, Cellular and Molecular Biology

• UC San Diego

  Specialized Certificate, Applied Bioinformatics

• National University

  Master's degree, Business Administration

• UC San Diego

  Specialized Certificate, Biofuels Science Technology

Skills

• Microbiology
• Hardware Diagnostics
• Online Business Management
• Dna
• Life Sciences
• Ivd
• Mba
• Sequence Analysis
• Immunology
• Assay Development
• Analytical Chemistry
• Molecular Biology
• Glp
• Rt-Pcr
• Qpcr
• New Business Development
• Lims
• Elisa
• Fda
• Dna Sequencing
• Cell Culture
• Cloning
• Chromatography
• Cell Biology
• Business Development
• Biochemistry
• Genomics
• Molecular Diagnostics
• Technology Transfer
• Sds-Page
• Immunoassays
• Drug Discovery
• Oncology
• Biotechnology
• Commercialization
• Infectious Diseases
• Cell
• Alternative Fuels
• Cancer
• Biopharmaceuticals