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Katelin Hawbaker

@katelinhawbaker

PhD-level life scientist specializing in GLP/FDA-compliant documentation and data management for submission-ready research.

United States
Message

What I'm looking for

I’m looking for a role where I can apply GLP/FDA-compliant documentation and ALCOA++-ready data management to support NDA/submission work. I want a compliance-driven environment with strong cross-functional collaboration and clear expectations for accurate records.

I’m a detail-oriented PhD-level life scientist with a strong foundation in data management, meticulous record-keeping, and regulatory compliance. I’m trained in GLP, FDA regulatory guidelines, and ALCOA++ documentation standards, and I consistently maintain accurate, retrievable scientific records in compliance-driven environments.

Across contract research and academic settings, I’ve supported NDA submissions by maintaining strict documentation and tracking multi-step toxicology study data under tight timelines. I’ve also designed, executed, and documented complex multi-step assays—including in vivo drug treatments, immunohistochemistry, and next-generation sequencing—while ensuring data entry and retrieval stayed accurate across projects.

Currently, as a Biology Expert (AI Model Evaluator), I apply rigorous documentation and organizational standards to evaluate and test life science knowledge outputs, emphasizing cross-functional collaboration and compliant, submission-ready results. I bring strong communication, organization, and multitasking skills—backed by RAPS and clinical research training—to help teams produce credible, reproducible work.

Experience

Work history, roles, and key accomplishments

Education

Degrees, certifications, and relevant coursework

National Institutes of Health (NIH) logoNN

National Institutes of Health (NIH)

Certification, Clinical Research

2026 - 2027

Completed the NIH Certification in Principles and Practices of Clinical Research.

Indiana University–Indianapolis logoIU

Indiana University–Indianapolis

Doctor of Philosophy (Ph.D.), Biology (Cellular and Molecular)

2020 - 2025

Earned a Ph.D. in Biology (Cellular and Molecular) at Indiana University–Indianapolis.

Regulatory Affairs Professionals Society (RAPS) logoRR

Regulatory Affairs Professionals Society (RAPS)

Regulatory Affairs Certificate, Medical Devices and Pharmaceuticals

2026 -

Completed a Regulatory Affairs Certificate focused on Medical Devices and Pharmaceuticals through RAPS.

Indiana University–Purdue University–Indianapolis logoIU

Indiana University–Purdue University–Indianapolis

Bachelor of Arts (B.A.), Biology & Spanish

2016 - 2020

Earned a B.A. in Biology and Spanish (Honors) at Indiana University–Purdue University–Indianapolis.

Tech stack

Software and tools used professionally

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