Zunera Khan
Summary
Senior Associate with a strong track record in quality control and assay development, executing potency and bioactivity tests while managing complex sample lifecycles. Developed and validated innovative assay platforms, driving compliance and optimizing workflows through effective mentoring and cross-departmental collaboration.
Overview
6
6
years of professional experience
Work History
Senior Associate, Internal Quality Control
Eli Lilly
Boston, Massachusetts
07.2025 - Current
- Executed potency, identity, and bioactivity testing on 34 of 43 samples, ensuring compliance with quality standards and supporting product release timelines.
- Authored and reviewed Certificates of Analysis (CoAs) for 15+ drug substance/product lots, ensuring on-time release to support manufacturing timelines
- Authored, revised, and reviewed 5+ controlled SOPs and quality control test methods to maintain compliance and improve assay consistency
- Developed and validated improved potency assay platform, including Benchling template design and cross-training of team members via OJT
- Performed statistical trending analysis (JMP) on reference standard stability data to support ongoing shelf-life and stability programs
- Managed sample lifecycle for 500+ vials from intake to disposition, optimizing processes in cell banking, media/reagent preparation, and cell culture maintenance.
- Supported quality systems initiatives including OOS (Out-Of-Specification) investigations, shelf-life extension approvals, and lab investigation script validation in Veeva QMS
- Acted as subject matter expert (SME) for Next Generation Sequencing testing during internal audits, providing critical insights that ensured adherence to regulatory requirements.
- Completed leadership development training through Bentley university and mentored junior analysts on assay technique and documentation practices
Analyst II, Quality Control
Verve Therapeutics
Boston, Massachusetts
02.2025 - 07.2025
- Qualified and performed nucleic acid analysis across three critical QC platforms in six months.
- Executed 42 release testing samples for AAV-based gene therapy. Independently managed 45% of departmental sample volume without product-impacting deviations.
- Led NGS troubleshooting, designed protocols, and optimized concentration for improved assay reliability.
- Identified and corrected SOP errors, increasing assay yield and eliminating protocol ambiguity.
- Resolved over eight deviations with zero sample impact, supporting internal audits and investigations.
- Authored and revised three major SOPs, enhancing compliance and usability for QC test methods.
- Reviewed and approved 99 Benchling records, achieving nine consecutive perfect documentation reviews.
Senior Research Associate, Process Development
Verve Therapeutics
Boston, Massachusetts
02.2024 - 01.2025
- Led gRNA design and optimization initiatives, incorporating novel chemistry modifications to enhance RNA stability and therapeutic potency, while advancing base editing and novel genome-editing modalities through strategic design and cross-functional collaboration.
- Executed specialized transfection procedures with LNPs and Lipofectamine and performed DNA/RNA extraction using Kingfisher and manual methods to support downstream applications.
- Optimized in vitro screening methods, conducted genomic analyses (dPCR and NGS), and troubleshot experimental challenges while performing cell culture maintenance in Huh7 cells and Primary Human Hepatocytes to support therapeutic candidate advancement.
- Drove cross-functional collaboration through lab operations forums, integrating workflows between R&D and safety teams, while serving as a liaison on the cell culture core team. Championed knowledge sharing via workshops and career development initiatives to foster team growth and scientific expertise.
- Drove cross-functional collaboration through lab operations forums, integrated workflows between R&D and safety teams, and served as liaison on cell culture core team, enhancing knowledge sharing through workshops and career development initiatives.
Research Associate
Verve Therapeutics
Boston, Massachusetts
10.2022 - 02.2024
- Acquired hands-on experience in RNA chemistry and genome editing through tissue culture experiments, optimizing mRNA/gRNA transfection protocols and advancing CRISPR/Cas9 modalities.
- Contributed to PhD-level research initiative on novel IVT enzyme protein production, resulting in publication.
- Developed molecular biology expertise through plasmid construction, sequence verification, HPLC analysis, and dPCR/RT-qPCR/NGS workflows for GLP toxicology studies.
- Presented findings to cross-functional teams, enhancing technical communication and quality assurance practices with Benchling for record-keeping.
- Executed critical project needs during rotation with quality control team, analyzing 1,500 GLP toxic study samples for Phase 1 clinical trial clearance.
- Trained on validated RT-qPCR and NGS workflows, mastering 70 SOPs through Veeva training.
Research Technician II
Duke School of Medicine - Center for AIDS Research, Ferrari Lab
Durham, NC
04.2021 - 10.2022
- Executed ADCC assays and evaluated IgG antibody binding to Spike-expressing cells via flow cytometry, contributing to understanding immune responses in HIV-1 and SARS-CoV-2 vaccine studies.
- Performed ADCC assays and evaluated IgG antibody binding to Spike-expressing cells using flow cytometry to assess immune responses in HIV-1 and SARS-CoV-2 vaccine studies.
- Conducted molecular biology techniques (PCR, gel electrophoresis, plasmid work) and maintained BSL-2+ lab operations while managing cell lines and developing SOPs to optimize data management and laboratory workflows.
Trainee Technologist, Molecular Microbiology/HLA
LabCorp
Burlington, NC
08.2020 - 03.2021
- Conducted specialized molecular diagnostic testing for SARS-CoV-2 and other viral samples, ensuring timely and accurate results during the pandemic
- Performed DNA/RNA extraction and isolation, and PCR-based genetic testing per standard operating procedures, while documenting preventive maintenance and quality control to maintain compliance
- Utilized King Fisher, Hamilton/MagEx, and MagNA Pure automated systems for efficient testing of SARS-CoV-2 samples
Education
Bachelor of Science - Molecular Biology
University of Denver
Denver, CO06-2020
Skills
- Quality control processes
- Assay development
- PCR techniques
- PCR and DNA purification
- gRNA optimization
- Transfection techniques
- Cell culture practices
- Experimental design troubleshooting
- Data analysis
- Documentation
- GMP/GLP compliance
- Laboratory management
- Technical writing
- Excel and PowerPoint
- Quality systems training
Publications
Engineered T7 RNA polymerase to improve mRNA capping efficiency and reduce dsRNA generation during in vitro transcription
Athul Sanjeev 1 2, Casey Hannigan 1, Ryan Garrity 1, Dhinesh Srinivasan Kamalakkannan 1, Victoria Clendaniel 1, Manini Mantri 1, Zach Glass 1, Lisa N. Kasiewicz 1, Jay Leipheimer 1, Zunera Khan 1, Taiji Mizoguchi 1, Vian Peshdary 1, Caroline R. Summers 1, Penny J. Beuning 2, Christopher J. Cheng 1
Timeline
Senior Associate, Internal Quality Control
Eli Lilly
07.2025 - Current
Analyst II, Quality Control
Verve Therapeutics
02.2025 - 07.2025
Senior Research Associate, Process Development
Verve Therapeutics
02.2024 - 01.2025
Research Associate
Verve Therapeutics
10.2022 - 02.2024
Research Technician II
Duke School of Medicine - Center for AIDS Research, Ferrari Lab
04.2021 - 10.2022
Trainee Technologist, Molecular Microbiology/HLA
LabCorp
08.2020 - 03.2021
Bachelor of Science - Molecular Biology
University of Denver