Tracy Ellen Sevilla
KBI Biopharma
Denver,CO
1
Language
23
years of professional experience
Accomplished Scientist with 22 years of analytical laboratory experience, including over three years in FDA-regulated biopharmaceutical manufacturing within cGMP environments. Expertise includes analytical characterization of biologics, method qualification, stability testing and trending, and quality systems following ICH guidelines. Collaborates effectively across Quality Assurance, Manufacturing, and Project Management to ensure compliant analytical testing and inspection readiness.
Work History
Scientist I
1 Year 1 Month- Perform analytical testing supporting batch release, stability, and forced degradation studies for protein therapeutics in a cGMP laboratory.
- Apply analytical techniques including HPLC, ELISA, CE-SDS, and PCR to support client manufacturing programs.
- Author analytical method qualification protocols, validation documentation, laboratory investigations, and technical reports.
- Successfully qualified 8-10 analytical methods across three client projects, from authoring qualification protocols, performing testing, and completing summary qualification reports.
- Supported deviation, CAPA, and OOS investigations through thorough scientific data review and root cause analysis to uphold quality standards.
- Collaborated with manufacturing, quality assurance, process development, and project management to ensure timely project execution and adherence to regulatory compliance standards.
- Maintain inspection readiness through strict adherence to FDA cGMP requirements and Good Documentation Practices.
- Troubleshot analytical methods and laboratory issues, enhancing method reliability and operational efficiency.
Associate Scientist
2 Years 10 Months- Conducted biochemical and biophysical testing to support biologics manufacturing and optimize process development.
- Executed analytical methods for batch release, stability, and characterization studies to ensure compliance and product quality.
- Contributed to laboratory investigations and analytical troubleshooting to resolve issues and enhance testing accuracy.
- Contributed to laboratory investigations and analytical troubleshooting activities.
- Worked closely with multidisciplinary teams to meet client deliverables while maintaining GMP compliance.
- Assisted in maintaining laboratory quality systems and audit readiness.
Chemist
9 Years 2 Months- Conducted analytical testing of approximately 10-15 industrial wastewater samples using EPA-approved methodologies per day.
- Reviewed analytical data for accuracy, quality control compliance, and regulatory reporting.
- Reviewed analytical data to ensure accuracy, compliance with quality control standards, and readiness for regulatory reporting.
- Maintained chain-of-custody documentation and laboratory records to uphold regulatory compliance and data integrity.
- Supported laboratory quality initiatives by adhering to SOPs and implementing quality control procedures.
Quality Assurance Manager
1 Year 4 Months- Managed quality assurance activities to ensure compliance and reliability in environmental testing operations.
- Reviewed laboratory data and analytical reports for quality and accuracy.
- Reviewed and validated laboratory data and analytical reports to ensure quality and accuracy for regulatory compliance.
- Maintained and revised SOPs to ensure compliance with regulatory requirements.
- Oversaw quality control systems, ensuring adherence to standards for laboratory accreditation.
Chemist II
2 Years 4 Months- Conducted chemical analyses of wastewater, ensuring compliance with environmental regulations and safeguarding public health.
- Developed and implemented quality control protocols that increased laboratory efficiency and accuracy in testing processes.
- Trained junior chemists on analytical techniques and laboratory safety procedures, fostering a culture of excellence and safety.
- Collaborated with cross-functional teams to identify process improvements in water treatment operations.
Chemist
2 Years 6 Months- Analyzed wastewater, soil, and sludge samples to ensure environmental compliance and safety standards.
- Maintained and troubleshot HPLC, ICP-OES, and ion chromatography instrumentation to ensure optimal performance and reliability.
- Supported laboratory audits and certification activities to uphold quality assurance and regulatory compliance.
- Supported laboratory audits, certification activities, and quality assurance programs.
Laboratory Technician
3 Years 1 Month- Prepared environmental samples through extraction and digestion techniques to ensure accurate analytical results.
- Conducted analytical testing of wastewater, drinking water, soils, and sludge to support environmental safety and regulatory compliance.
- Ensured compliance with laboratory SOPs and quality control requirements to uphold testing integrity and reliability.
Education
Bachelor of Arts - Chemistry
Graduate Certificate in Bioprocess Engineering - Bioprocess Engineering
Skills
Analytical Development
Method Validation
Assay development
Chromatography - HPLC
ELISA
Biologics
Quality Assurance
FDA/cGMP/GDP/ICH
OOS investigations
Validation
Audit Readiness
Technical Writing
Cross-functional Collaboration
Peer review process
Stability Studies
Drug Substance/Drug Product Testing
Languages
French
Limited Working
Timeline
Scientist I
KBI Biopharma
07.2025 - CurrentRead More
Associate Scientist
KBI Biopharma
09.2022 - 07.2025Read More
Chemist
City and County of Denver
06.2013 - 08.2022Read More
Quality Assurance Manager
Nevada Analytical Services
02.2012 - 06.2013Read More
Chemist II
Clark County Water Reclamation
09.2009 - 01.2012Read More
Chemist
Silver State Analytical Laboratories
03.2007 - 09.2009Read More
Laboratory Technician
Great Basin Laboratories
01.2004 - 02.2007Read More
Colorado State University
Graduate Certificate in Bioprocess Engineering from Bioprocess Engineering
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University of Nevada, Las Vegas
Bachelor of Arts from Chemistry
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