Madelene E. Clark
Gaithersburg,
Summary
Results-driven scientist and process engineer with over three years of experience in GMP-compliant biopharma environments. Specializes in quality control, analytical lab operations, and process optimization, with a proven track record in flow cytometry. Led a six-month DMAIC lab testing project achieving an error rate of less than 1%, ensuring robust data integrity. Currently pursuing an MBA in Business Analytics to enhance strategic decision-making and cross-functional impact.
Overview
10
10
years of professional experience
Work History
Process Engineer
Kite, a Gilead Company
Frederick
09.2024 - Current
- Lead and trained a DMAIC investigative lab testing team of 22 people, analyzing 620 biological samples with a 1% invalid rate over a 6-month period.
- Streamline and validate GMP manufacturing workflows to support commercial-scale cell therapy production.
- Partner with cross-functional teams in deviation management, process monitoring, and control strategy execution.
- Spearhead continuous improvement initiatives using Lean and Six Sigma methodologies.
- Analyze and present process monitoring data using SQL and JMP, delivering actionable insights to site leadership on a routine basis.
QC Analytical Lab Specialist
Kite, a Gilead Company
Frederick
10.2022 - 09.2024
- Executed routine and specialized testing of cell banks using flow cytometry, qPCR/ddPCR, ELISA, pH, and osmolarity under GMP.
- Supported compliance through CAPA management, deviation investigations, change controls, and OOS reporting.
- Mentored peers and new hires as a qualified trainer and flow cytometry SME.
- Oversaw equipment lifecycle and testing readiness, aligned with FDA and USP requirements.
Scientist (Contractor)
Eurofins Scientific - Kite, a Gilead Company
04.2022 - 10.2022
- Performed microbial environmental monitoring, sterility, and endotoxin testing in ISO-classified cleanrooms.
- Maintained strict GMP documentation and aseptic technique during QC support operations.
Soil Microbiology Graduate Assistant
Purdue University
05.2021 - 04.2022
- Conducted microbial laboratory testing to assess contaminant degradation and microbial community responses to heavy metals, PFAS (Per- and Polyfluoroalkyl Substances), and PHAs (Polyhydroxyalkanoates) in soil and water systems.
- Trained and supervised a cohort of visiting Colombian exchange students, providing hands-on instruction in laboratory safety, microbial assay execution, and environmental data analysis.
- Collaborated with multidisciplinary teams to support Department of Defense-funded environmental monitoring and remediation research efforts.
Biochemical Carbon Modeling Intern
University of Florida
Gainesville
05.2020 - 09.2020
- Built microbial carbon cycle models using R Studio to support climate pricing frameworks in Canada.
Undergraduate Research Assistant - Soil Fertility & Agroecosystems
University of Florida / Princeton MPALA
Kenya & Gainesville
05.2019 - 08.2020
- Led an international team of 11 in conducting wet lab chemistry, spectrophotometry, and field interviews to analyze small-share farm ecosystems.
Microbiologist I
Merieux NutriSciences
Gainesville
06.2017 - 02.2019
- Conducted FDA/USDA-aligned food safety testing using AOAC and FDA BAM protocols.
- Provided leadership support and troubleshooting in a high-throughput microbial testing lab.
Additional Internships
University of Florida
01.2016 - 04.2020
- Teaching Assistant, Microbiology Summer Lab Series
- McKnight Brain Institute Intern (Gut-Brain Axis Phase II Clinical Research)
- Microbiology and Cell Science Lab Intern
- Biogeochemistry Research Assistant
Education
Master of Business Administration (MBA) -
Purdue Global University
12.2025
Bachelor of Science - Soil and Water Science (Microbiology Focus)
University of Florida
Gainesville, FLAssociate of Arts - Biology, Honors
Santa Fe College
Gainesville, FLInternational Baccalaureate (IB) Diploma -
Eastside High School
Gainesville, FLSkills
- Techniques: Flow Cytometry, ELISA, qPCR/ddPCR, BAX PCR, endotoxin testing, sterility, pH, Osmolarity, Accellix
- Regulatory: GMP/GDP, CAPA, Change Control, OOS investigation, deviation management
- Software: Microsoft Office Suite, LIMS, Smartsheet, R Studio, SQL, JMP
- Tools: DMAIC, Lean/Six Sigma (non-certified), Statistical Process Control (SPC) basics
- Process Engineering Quality Control GMP Manufacturing DMAIC Investigations Continuous Improvement Lab Operations Data Integrity Microbial & Analytical Testing Team Leadership Executive Reporting Strategic Analysis Communication
Timeline
Process Engineer
Kite, a Gilead Company
09.2024 - Current
QC Analytical Lab Specialist
Kite, a Gilead Company
10.2022 - 09.2024
Scientist (Contractor)
Eurofins Scientific - Kite, a Gilead Company
04.2022 - 10.2022
Soil Microbiology Graduate Assistant
Purdue University
05.2021 - 04.2022
Biochemical Carbon Modeling Intern
University of Florida
05.2020 - 09.2020
Undergraduate Research Assistant - Soil Fertility & Agroecosystems
University of Florida / Princeton MPALA
05.2019 - 08.2020
Microbiologist I
Merieux NutriSciences
06.2017 - 02.2019
Additional Internships
University of Florida
01.2016 - 04.2020
Master of Business Administration (MBA) -
Purdue Global University
Bachelor of Science - Soil and Water Science (Microbiology Focus)
University of Florida
Associate of Arts - Biology, Honors
Santa Fe College
International Baccalaureate (IB) Diploma -
Eastside High School
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