Data Management

DAKOTA CARLSON

***********@*****.*** 316-***-**** 336 Charlie Court, Apartment 3D, Portage, MI 49002 SUMMARY

• Researcher within the pharmacological field working in a pre-clinical and early clinical drug research, focused on Biomarkers, small and large molecules, Ligand-binding assays, and RNA assay. EDUCATION

SKILLS

• ELISA, electrochemiluminescence, and fluorescence immunoassay Experiments

• Dev elop, and v alidate Bioanalytical, RNA, Cell and ligand- binding assay methods for clinical and non-clinical studies.

• Separation/purification techniques of proteins/analytes.

• PPE, SPE, and SLE extractions of Small molecules.

• Quantitative Bioanalytical data analysis.

• Laboratory safety

• Instrument maintenance and calibration

• Organizational skills

• Instrument maintenance and inv entory management of supplies and prep of lab materials and stock solutions.

• Detail Oriented and experienced with Clinical Chemistry and Pathology.

• Report writing

• Interpersonal and written communication

• Project management

• LC-MS/MS, UPLC, and spectrophotometers.

• Cell/Tissue/Bacteria Cultures experiments and aseptic technique.

• Branched DNA/RNA experiments and problem solving.

• Data management through Excel, Watson (Pilot,

Production, and IRM), and LIMS.

WORK HISTORY

May 2018 - Current

Quality Inspector

Pfizer Inc.

Kalamazoo, MI

• Validation support for multiple projects, including protocol and report development, data v erification, deviation and change control assessments.

• Lead re-v alidation projects and responsible for Clean Equipment Hold Time study

• Establish an Upper Blend Time for Micronized Products study.

• Create and update cleaning validation protocols, reports and records.

• Organize required audit documentation for cleaning and process v alidation.

• Actively participate with auditors during multi-customer audits.

• Ev aluate and summarize all process v alidation activities performed in Annual Product Record Rev iews (APRRs).

• Dev elop Qualified Equipment Periodic Review Reports for several units.

• Updating documents, cleaning procedures, and SOP work. Nov 2016 - Jan 2018

Research Associate

Dept of Bioanalytics

MPI Research

Mattawan, MI

• Pioneered as first RA cross functionally trained in three different critical branches of research.

• Analyzed test article samples to determine pharmacokinetic and anti-drug antibody profiles in matrices to meet or precede pass rates of 95%.

• Performed quantitative sample analysis to determine RNA binding efficiency of specific gene targeting drugs

• Analyzed nucleotides, peptides and steroid samples using LC/MS

• Worked with method development scientists to efficiently adapt and v alidate bioanalytical and Ligand-binding assay methods

• Assisted with process improvements, such as creating and implementing new documentation design for pharmacokinetic assays

• Increased wet lab work efficiency through documented data and experimental design for GLP standard lab work.

MAY 2016

Bachelor of Science: Biochemistry

PITTSBURG STATE UNIVERSITY.

• Minored in Biology

• Conducted research on gene expression of hnRNP C, hRaly and hRalyl proteins associated with pre-mRNA processing and subsequent v ector insertion into E. Coli plasmid.

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