Lindsay Burke
Niles,OH
Summary
Detail-oriented Certifying Scientist with extensive laboratory experience in FDA and cGMP chemistry quality control and clinical toxicology labs. Expertise in LC/MS/MS analysis. Combines excellent problem-solving and communication skills to deliver accurate and reliable results while supporting regulatory compliance.
Overview
22
22
years of professional experience
Work History
Certifying Scientist
M1 Labs LLC
Columbiana, OH
08.2020 - 04.2026
- Execution of testing as well as daily maintenance and basic troubleshooting on LC/MS/MS models: AB Sciex 5500+ QTrap Mass Spectrometer, AB Sciex 5500 QTrap Mass Spectrometer, and AB Sciex 4500 MD Mass Spectrometer using Analyst software
- Proficient in quantification of LC/MS/MS data using Multiquant software
- Investigated batch failures and retests, identifying root causes and implementing resolutions
- Generated quality control data while maintaining comprehensive tracking spreadsheet for accuracy
- Quantification of proficiency testing results as well as data submission: CAP, API, PA Proficiency
- Proficient in entering orders, releasing reports and building client-specific reports in StratusDX
- Facilitated entry of patient reports into client-specific EMRs, ensuring timely and accurate data delivery
- Answered client questions regarding results, including potential drug interactions
- Assisted in designing experiments for correlation testing, validation testing, and method improvement.
- Maintained specimen problem log, processing and communicating any sample rejections
- Set up testing batches for both urine and oral fluid samples according to SOPs
Toxicologist
Biomedical Laboratories
Hubbard, OH
05.2018 - 08.2020
- Executed testing and performed daily maintenance on LC/MS/MS models: AB Sciex API 4000 and API 4500 using Analyst software.
- Proficient at quantification of data generated using Multiquant software
- Processed patient urine specimens for drug screen and confirmation testing on LC/MS/MS using both manual set up techniques as well Tecan plate setup (Tecan Freedom EVO 150 with EvoWare software)
- Assisted in creating and updating SOPs according to CAP requirements
- Generated patient reports using Comtron Labgen as well as Avalon
Quality Control Team Lead
Avantor/VWR/AMRESCO, LLC
Solon, OH
05.2006 - 05.2018
- Member of Manufacturing Problem Batch team – identify root causes for batch issues
- Contributed to Supplier Incoming Event team, enhancing alignment with suppliers to minimize raw material rejection rates
- Facilitated material and product flow through lab by coordinating communication among production control, purchasing, and manufacturing departments
- Assisted in progression planning for all QC technicians as well as training in new techniques
- Directly communicated with customers during audit tours in the lab
- Scheduled and closed orders to be used by production control in LIMS and inventory management systems
- Experienced with access-based LIMS system as well as web-based StarLIMS, including data entry, troubleshooting, and specification approval and implementation
- Supported Product Development by transferring new product testing procedures to the lab.
- Performed testing out of specification investigations
- Established weekly lab meetings to improve communication and collaboration within the team
- Proficient in laboratory technical documentation review
- Maintained product and raw material testing schedule as well as other duties above
- Quality Control Supervisor – 1 year
- Responsible for day-to-day operations in the QC lab including Out-of-specification investigations, prioritizing product release, maintaining lab throughput and staffing coverage with 20 direct reports
- Senior Technician - 4 years
- Performed testing for endotoxin, pyrogen, and nuclease contamination; PCR testing
- Clinical line testing: Dimension RxL, Hitachi, and Techion RA 1000
- Quality Control Technician - 1 year
- Experience in trace metal analysis via ICP (Inductively Coupled Plasma)
- Agarose and acrylamide gel electrophoresis
- Proficient in basic chemistry techniques: pH, conductivity, melting point, specific rotation, osmolality, FTIR analysis, titrations (manual and automatic), Karl Fischer titration, UV/Vis spectrophotometry
Adjunct Faculty
ITT Technical Institute
Youngstown, OH
05.2009 - 08.2009
- Instructed a newly developed course, Survey of Sciences, that covered physics, earth science, chemistry, and biology topics.
Graduate Assistant
Youngstown State University
Youngstown, OH
08.2004 - 05.2006
- Instructed microbiology and molecular genetics labs for biology majors, setting up protocols and evaluating students in basic lab techniques including plating bacteria, staining, microscopy, pipette usage, DNA extraction, and gel electrophoresis to enhance practical skills and understanding.
- Taught genetics module of science course for non-science majors
- Conducted student evaluations and provided lecture coverage for professors, ensuring continuity of instruction and supporting student learning.
- Tutored biology majors in Genetics
Education
M.S. - Biology
Youngstown State University
Youngstown, OH12-2006
B.S. - Biology
Youngstown State University
Youngstown, OH05-2004
Skills
- LC/MS/MS analysis
- Multiquant software
- Regulatory compliance
- Method validation
- Quality control processes
- SOP development
Awards
- Dean's Award for Excellence in a Presentation at QUEST, YSU, 04/06
- Session Awards at the Conference on Undergraduate and Graduate Research, University of Akron, 11/05
- Phi Kappa Phi inductee, 03/06
- Omicron Delta Kappa inductee, 03/05
- Panel member and laboratory demonstration support for the Women in Science and Engineering Career Day at YSU
Additional Laboratory Experience
Undergraduate & Graduate Research: Youngstown State University 01/02 - 12/06
- Proficient in DNA isolation from yeast and bacterial cells, DNA purification, restriction enzyme digestion, 1-D and 2-D gel electrophoresis, Southern blotting, transformations, PCR and solution & media preparation
- Experience with DNA sequencing, protein gel electrophoresis, mammalian cell culture maintenance, gene isolation and amplification
- Experience operating Ultracentrifuge, Sorvall centrifuge, PCR thermocycler
- Experience with immunological techniques such as hemacytometer counts, mammalian cell culture, hybridoma preparation, ELISAs
Timeline
Certifying Scientist
M1 Labs LLC
08.2020 - 04.2026
Toxicologist
Biomedical Laboratories
05.2018 - 08.2020
Adjunct Faculty
ITT Technical Institute
05.2009 - 08.2009
Quality Control Team Lead
Avantor/VWR/AMRESCO, LLC
05.2006 - 05.2018
Graduate Assistant
Youngstown State University
08.2004 - 05.2006
M.S. - Biology
Youngstown State University
B.S. - Biology
Youngstown State University