Emma Quill
Cleveland Heights
Summary
Research scientist and manufacturing lead with experience in drug product formulation, IND-enabling development, CMC support, and preclinical research. Skilled in therapeutic product manufacturing, production oversight, CPP/CQA identification, SOP development, analytical HPLC method development support, stability evaluation, and quality-focused documentation. Recognized for hands-on technical execution, equipment troubleshooting, process optimization, team mentorship, and cross functional problem-solving in fast-paced biotech environments.
Overview
5
5
years of professional experience
Work History
Head Manufacturer
Haima Therapeutics
Cleveland
04.2026 - Current
- Lead manufacturing activities for therapeutic product development, including production of the lead formulation selected for the FDA IND submission.
- Developed and optimized manufacturing processes, including identification and documentation of critical process parameters and critical quality attributes for the CMC section of the IND.
- Manufactured investigational product batches supporting preclinical and regulatory development milestones.
- Established and maintained accurate production records, material usage documentation, and batch-related release specifications to support regulatory and quality review.
- Partnered with scientists to create regulatory strategy for manufacturing scale up for Human Clinical Trials.
- Trained team members on equipment operation, production procedures, safety protocols, and manufacturing best practices.
Research Scientist II
Haima Therapeutics
Cleveland
04.2026 - Current
- Led laboratory relocation activities, coordinating equipment setup, workflow organization, and operational readiness for research and manufacturing functions.
- Established a manufacturing solvent collection method to improve waste handling, process organization, and laboratory safety practices.
- Served as the primary point of contact for equipment troubleshooting, maintenance coordination, and process-continuity solutions across laboratory and manufacturing operations.
- Analyzed experimental and manufacturing data to identify trends, support process improvements, and inform development strategy.
- Collaborated cross-functionally with scientific, external,and regulatory team members to support IND-enabling development activities.
- Prepared technical reports, experimental summaries, and documentation used in internal decision-making and regulatory planning.
Research Scientist I
Haima Therapeutics
Cleveland
04.2024 - 04.2026
- Conducted laboratory experiments supporting drug development, formulation evaluation, and preclinical research initiatives.
- Developed and implemented a standardized small-animal necropsy protocol to assess observable drug-related toxicities and improve consistency of preclinical safety evaluations.
- Established product handling parameters, including post-reconstitution use window, discard timing, optimal storage conditions, and drug stability considerations.
- Assisted in developing HPLC method to identify drug components and quantify product purity and concentration.
- Authored SOPs for reconstitution, storage, and product-use procedures to improve consistency, documentation, and internal quality practices.
- Mentored junior scientists and interns on laboratory techniques, data documentation, and safety procedures.
Research and Development Intern
Haima Therapeutics
Cleveland
10.2021 - 04.2024
- Assisted with animal research studies evaluating drug efficacy, dose tolerability and treatment response.
- Supported drug manufacturing and formulation activities to ensure project timelines and experimental requirements were met.
- Conducted quality assurance checks on manufactured drug products according to internal release standards.
- Contributed to grant-funded research projects through literature review, experimental support, and data analysis.
- Maintained laboratory organization, cleanliness, and operational readiness to support daily research activities.
Education
Bachelor of Science - Biomedical Engineering
University of Akron
Akron, OH05-2024
Skills
- Drug Product Manufacturing
- Quality Control Testing and Component Characterization
- Batch Documentation
- Formulation Development and Evaluation
- IND Enabling Development/CMC Support
- HPLC Method Development Support
- SOP Development/Implementation
- Technical Reporting
- Preclinical Toxicity Assessment Support
- Small-Animal Necropsy and Surgeries
- Regulatory Compliance
- Laboratory Operations
- Equipment Troubleshooting
- Practical Engineering/Problem Solving Solutions
Publications
- Dexamethasone-loaded platelet-inspired nanoparticles improve intracortical microelectrode recording performance
- Systemically administered platelet-inspired nanoparticles to reduce inflammation surrounding intracortical microelectrodes
- Lyophilized Synthetic Platelets: In Vitro Characterization and in Vivo Evaluation in Mouse Thrombocytopenia Model
- Intraosseous administration of lyophilized synthetic platelets renders hemostatic efficacy in rat model of traumatic hemorrhage
- Post-Injury Treatment with Rapid Intraosseous Injection of Lyophilized Synthetic Platelets Enhances Survival, Hemostasis, and Hemodynamics in a Rat Model of Liver Laceration
- Utilizing Static And Flow Assays To Assess Safety Of Synthetic Platelets Ex Vivo
Affiliations
- Cleveland Woman in Biotech Steering Committee - Cleveland OH (Present)
- Pride Committee - St. Paul's Episcopal Church, Cleveland Heights, OH (Present)
- Rector Search Committee - St. Paul's Episcopal Church, Cleveland Heights, OH (2024-2025)
- Hobbies: designing, building, and maintaining vivariums with insects, amphibions and aquatic life; insect pinning; mountain biking; hiking; kyaking; fishing; skiing; gem, mineral, and fossil collecting; gem faceting; diaphonisization perservation; plant keeping; jewlery making; flower pressing; home-brewed kombucha.
Timeline
Head Manufacturer
Haima Therapeutics
04.2026 - Current
Research Scientist II
Haima Therapeutics
04.2026 - Current
Research Scientist I
Haima Therapeutics
04.2024 - 04.2026
Research and Development Intern
Haima Therapeutics
10.2021 - 04.2024
Bachelor of Science - Biomedical Engineering
University of Akron