Summary
Overview
Work History
Education
Skills
Accomplishments
References
Timeline
Generic

Stephanie Wallace-Teliz

Tampa,FL

Summary

Successful Scientific Project Manager with extensive experience overseeing pharmaceutical biomarker, pharmacokinetics (PK), and immunogenicity analyses across large and small-scale studies. Proven track record managing projects end-to-end, including assay development, protocol and plan writing, study execution, data analysis, and comprehensive report finalization. Skilled at interpreting and communicating complex scientific data clearly to diverse audiences and foster robust client relationships. Experienced in a dynamic startup environment, driving operational improvements that enhance efficiency while ensuring regulatory compliance and client satisfaction. Strong verbal and written communication skills combined with a proactive learning mindset, enabling rapid adaptation to new scientific and project management challenges.

Overview

9
9
years of professional experience

Work History

Bioanalytical Principal Investigator II

Immunologix Laboratories
Tampa, FL
10.2024 - 01.2026
  • Independently provided regulatory and scientific oversight of regulated and non-regulated bioanalytical studies, ensuring strict compliance with GxP standards and internal SOPs.
  • Analyzed, interpreted, and approved study data, delivering accurate and timely reports aligned with Sponsor requirements.
  • Acted as primary point of contact for Sponsors and Study Directors, maintaining effective communication and fostering strong client relationships.
  • Prepared and reviewed Sample Analysis Plans (SAP), validation plans, and study documentation to ensure adherence to protocols and quality standards.
  • Initiated new projects including setting up Sponsor-specific files, and designing Watson LIMS study workflows.
  • Coordinated analytical batch creation, data reduction, review processes, and final report preparation in accordance with SOPs and ready for QC/QAU review.
  • Ensured all study personnel were trained on applicable SOPs, protocols, and amendments to maintain compliance and data integrity.
  • Maintained workflow metrics, developed review schedules, and tracked project progress to ensure on-time delivery of study milestones.
  • Prepared and reviewed SOPs, protocol deviation reports, and corrective action plans, promptly addressing and escalating quality issues as needed.
  • Collaborated with Laboratory Management, Method Development/Validation, QC, QA, and Reagent Groups to allocate resources for assay execution.
  • Scheduled and coordinated study reviews with QC and audit events with QAU, ensuring timely resolution of findings and corrective actions.
  • Troubleshot assay methods in coordination with method development teams, conducting laboratory investigations and reporting outcomes.
  • Documented and maintained Sponsor meeting minutes, critical communications, and ensured timely transfer of data and records.
  • Contributed to continuous improvement initiatives by writing and reviewing SOPs and refining project tracking processes.
  • Lead training and mentorship on study protocols, SOPs, and GxP compliance.
  • Serve as an operational resource, identifying opportunities and driving continuous improvement initiatives to optimize laboratory workflows and project execution.

Bioanalytical Principal Investigator I

Immunologix Laboratories
Tampa, FL
04.2022 - 10.2025
  • Functioned with a high degree of independence managing biomarker, PK, and immunogenicity assays for regulated preclinical and clinical studies.
  • Coordinated assay development, validation, and sample analysis aligned with GxP standards.
  • Prepared and reviewed detailed Sample Analysis Plans, validation documents, and regulatory reports.
  • Communicated complex scientific data effectively to Sponsors, Study Directors, and internal teams, adjusting messaging for varied audiences.
  • Assisted with training personnel and maintained compliance with SOPs and protocols.
  • Collaborated with cross-functional groups to ensure resource availability and study execution integrity.

Project Coordinator

Immunologix Laboratories
Tampa, FL
04.2021 - 04.2022
  • Assisted Principal Investigators by organizing lab work documentation and coordinating internal workflows to support timely study completion.
  • Submitted study data to Quality Control (QC) and Quality Assurance (QAU) teams, facilitating adherence to project timelines and regulatory standards.
  • Communicated regularly with laboratory teams, Quality Control (QC), and data-generating groups to ensure timelines were met and questions were promptly addressed.
  • Supported QC and QAU audit findings by collaborating with Principal Investigators during reviews and corrective action planning.
  • Accurately recorded meeting minutes for study team and sponsor meetings to ensure clear communication and documentation.
  • Conducted sample analysis studies including preparation of Watson LIMS batches and initial data review for acceptance under PI guidance.
  • Drafted deviation reports and study conduct summaries for Principal Investigator review and finalization.
  • Assisted in report writing to summarize study outcomes, ensuring clarity and regulatory compliance prior to PI approval.

Data Systems Analyst

Immunologix Laboratories
Tampa, FL
01.2020 - 04.2021
  • Generated biomarker, pharmacokinetic, and immunogenicity validation data tables for Sponsor review and reporting.
  • Developed custom scientific reporting templates according to bioanalytical plans.
  • Ensured compliance in data transfers using internal and external templates, maintaining accuracy.
  • Created internal templated data transfer agreements in collaboration with data management teams.
  • Collaborated with quality control team to deliver precise data outputs.
  • Designed Watson LIMS sample layouts aligned with pre-clinical and clinical protocols.
  • Utilized Microsoft Excel formulas to enhance data management efficiency.
  • Established workflows in Quality Management System for documenting deviations.

Laboratory Assistant

University of Tampa
Tampa, FL
08.2016 - 05.2019
  • Maintained safe, clean laboratory environment by adhering to SOPs and safety guidelines.
  • Guided students on proper chemical handling and equipment usage.
  • Adapted teaching methods to suit diverse student skill levels, improving learning outcomes.
  • Prepared chemical solutions and set up equipment for efficient class operations.
  • Facilitated communication with professors to ensure seamless laboratory workflows.
  • Supervised students and new assistants, promoting organized lab sessions.
  • Led meetings to review procedures and enhance team preparedness.
  • Provided educational support, assisting students with Excel for data analysis.

Education

Bachelor of Science - Forensic Science

University of Tampa, FEPAC Accredited
Tampa, FL
05-2019

Skills

  • Scientific Reporting and Documentation
  • Data Analysis and interpretation
  • Written & Verbal Communication
  • Project management
  • Problem Solving & Critical Thinking
  • Cross-functional collaboration
  • Regulatory Compliance (GxP) and Oversight

Accomplishments

Wallace-Teliz, S., et al. Rethinking Immunogenicity: An Integrated Approach Reveals the PK/PD Impact of Pre-existing and Drug-Sustaining ADA. Manuscript in preparation, 2026.

References

References available upon request.

Timeline

Bioanalytical Principal Investigator II

Immunologix Laboratories
10.2024 - 01.2026

Bioanalytical Principal Investigator I

Immunologix Laboratories
04.2022 - 10.2025

Project Coordinator

Immunologix Laboratories
04.2021 - 04.2022

Data Systems Analyst

Immunologix Laboratories
01.2020 - 04.2021

Laboratory Assistant

University of Tampa
08.2016 - 05.2019

Bachelor of Science - Forensic Science

University of Tampa, FEPAC Accredited
Stephanie Wallace-Teliz