Overview
Work History
Education
Skills
Timeline
Generic

Amanda Overby

Fargo ,ND

Overview

4
4
years of professional experience

Work History

Downstream Technical Lead

Aldevron
01.2023 - Current
  • Lead team of operators in purifying plasmid DNA within expected manufacturing timelines, delegate work content, strategize path forward through set-backs, adhere to standard work, and work with Quality department.
  • Directly enhanced pDNA work flow by designing instrumentation that contributed to 40% reduction in cycle time for processing leading to ARR of 66M for my direct team.
  • Consulted with DBSL team in implementing standard work, LEAN conversion and 5S. Navigate issues that arose, and was integral to implementation in 30L downstream teams (combined ARR of 200M).
  • Enhanced flow of 30L lots using 5S/Lean conversion, taking lead on room design and placement for optimal processing. Designed layout for my teams processing room initially, then was given the opportunity to 5S 3 other downstream production rooms, and provided advice on 300L 5S.
  • Consult with management and Technical Operations to improve batch records for more streamlined processing and error reduction.
  • Collaborate and consult in various cross functional roles, including working with Quality Assurance, Technical Operations and management, to maintain quality and schedule.
  • Train and mentor team members, providing educational expertise on technical concepts, trouble shooting techniques, processes, and cGMP/GDP standards.

Biomanufacturing Operator I

Aldevron
06.2021 - 01.2023
  • Mastered downstream purification processes. To include: alkaline lysis, various chromatagraphies using Cytiva AKTA READY equipment (including void mode chrom), Automated Diafiltrations using Cytiva AKTA READY FLUX equipment, Manual Diafiltration processing, Formulation, Plasmid Linearization, Spectrophotometry, Osmolality testing, resin preparation. Become proficient enough to obtain qualified trainer status working to train other team members.
  • Brainstormed improvement techniques for qualified trainers. Resulting in standardization of performance reviews, putting together knowledge expectations along with technical expectations in order for operators to be deemed proficient and signed off on processing events.
  • Maintain strict adherence to laboratory guidelines and regulations in accordance to GMP and GDP guidelines

Lab Assistant Phlebotomist

Sanford Medical Center
07.2020 - 05.2021
  • Obtained variety of blood samples for medical testing through venipuncture or capillary puncture using syringes, butterfly needles and straight needles.
  • Used electronic medical software, including EPIC, to conduct patient intakes and send correspondence in timely and organized manner.

Biochemistry Lab Assistant

NDSU
08.2019 - 05.2020
  • Directly assisted with input for scientific journal: Farmakes, J., Schuster, I., Overby, A., Alhalhooly, L., Lenertz, M., Li, Q., Ugrinov, A., Choi, Y., Pan, Y., & Yang, Z. (2020a). "Enzyme immobilization on graphite oxide (GO) surface via one-pot synthesis of go/metal–organic framework composites for large-substrate biocatalysis." ACS Applied Materials & Interfaces, 12(20), 23119–23126. https://doi.org/10.1021/acsami.0c04101
  • Work on protein synthesis, purification, and stabilization
  • Collaborated with team to develop ideas, produce theories and interpret data researched.
  • Exposure to biochemistry protocols such as: pH specificity, gel-electrophoresis, nanodrop spectrophotometer, FPLC, pipetting, and academic collaboration between groups/departments.

Education

Bachelor of Science - Biological Science

North Dakota State University
Fargo, ND
05.2021

Skills

  • Training/ Leadership
  • 5S/Lean Conversion
  • SOP and cGMP/GDP compliance
  • Lab Management
  • Improvement minded
  • Kaizen Certified

Timeline

Downstream Technical Lead

Aldevron
01.2023 - Current

Biomanufacturing Operator I

Aldevron
06.2021 - 01.2023

Lab Assistant Phlebotomist

Sanford Medical Center
07.2020 - 05.2021

Biochemistry Lab Assistant

NDSU
08.2019 - 05.2020

Bachelor of Science - Biological Science

North Dakota State University

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Amanda Overby