Emma Giberson
Manchester
Summary
Results-driven Quality Control Scientist with extensive experience in cGMP-compliant operations supporting AAV-based gene therapy products across clinical and commercial phases. Skilled in viral cell-based assays, mammalian cell culture, and advanced analytical techniques including qPCR, automated Western blot, ELISA, and immunohistochemistry. Proven expertise in method development, qualification, and validation in alignment with ICH guidelines, as well as authoring critical documentation such as SOPs, protocols, and reports. Adept at managing critical reagent lifecycle, laboratory assets, and cross-functional collaboration. Academic background in regenerative medicine research, including 3D bioprinting and tissue engineering.
Overview
12
12
years of professional experience
Work History
Senior Associate, Gene Therapy Quality Control
Sarepta Therapeutics
03.2025 - Current
- Supported cGMP-compliant quality control activities for critical reagents.
- Authored reagent qualification protocols, bridging protocols, qualification reports, and analytical test methods to ensure regulatory compliance.
- Led laboratory operations for critical reagent release, including inventory management, preparation, qualification, and release in collaboration with analytical development and QC teams.
- Routinely performed mammalian cell culture and potency assays in support of critical reagent qualifications.
- Experienced in change controls, electronic quality management systems, CAPAs and deviation management to maintain compliance and continuous improvement.
Biological Scientist III
Department of Health and Human Services
11.2024 - 03.2025
- Supported the molecular diagnostic team to identify and sequence infectious viruses and bacteria from human derived specimen. Utilized Clear Labs automated liquid handler to perform next generation sequencing on wastewater samples for SARS-CoV2 bioinformatics collection. Analyzed and interpreted test results, compiled data, and disseminated results for public health and safety purposes. Performed manual next generation sequencing methods for PulseNet foodborne illness tracking and SARS-CoV2 surveillance. Communicated test results to government agencies and impacted personnel.
Gene Therapy Potency Associate II
Sarepta Therapeutics
05.2022 - 11.2024
- Supported quality control operations in compliance with cGMP standards for AAV-based therapeutic products across early/late-phase clinical and commercial programs.
- Performed viral cell-based assays for release and stability testing; maintained cell banks and executed routine cell transduction, lysis, DNA extraction, protein quantification (automated western blot), and qPCR.
- Developed, qualified, and validated mammalian cell-based potency assays in alignment with ICH guidelines.
- Authored comprehensive documentation including development reports, analytical methods, testing protocols, protocol exceptions, and SOPs.
- Managed laboratory assets, including equipment induction, maintenance scheduling, and work request coordination
Tissue Fabrication Intern
Advanced Solutions
11.2021 - 05.2022
- Performed immunohistochemistry (IHC) and ELISA assays on various human tissue samples to support experimental objectives.
- Cultured human cells for 2D and 3D tissue constructs, ensuring viability and reproducibility of models.
- Isolated blood vessels from primary human tissue for downstream applications.
- Conducted microscopy imaging and quantitative analysis of tissue products to assess structural and functional integrity.
- Supported development of liver tissue models for NASH (Non-Alcoholic Steatohepatitis) research
Team Lead
U.S Army National Guard
01.2014 - 01.2022
- Oversaw, managed, and trained a team of 5 soldiers, ensuring operational readiness and compliance with military standards.
- Completed three full-time active-duty tours, including: Recruiting & Retention (2015): Supported talent acquisition and retention strategies for force readiness.
Middle East Deployment (2016–2017): Contributed to ongoing military operations in a high-pressure environment.
Logistics Assistant (2019–2021): Coordinated supply chain and resource management for mission-critical operations. - Specialized in Air Defense Artillery, providing expertise in tactical operations and defense systems.
Education
Master of Science - Biotechnology
University of New Hampshire
01-2022
Bachelor of Science - Biology
Plymouth State University
Skills
- Documentation: SOPs, protocols, validation reports, method development, method validation
- Analytical Techniques: qPCR, ELISA, Western blot, cell-based assays, potency assays
Timeline
Senior Associate, Gene Therapy Quality Control
Sarepta Therapeutics
03.2025 - Current
Biological Scientist III
Department of Health and Human Services
11.2024 - 03.2025
Gene Therapy Potency Associate II
Sarepta Therapeutics
05.2022 - 11.2024
Tissue Fabrication Intern
Advanced Solutions
11.2021 - 05.2022
Team Lead
U.S Army National Guard
01.2014 - 01.2022
Master of Science - Biotechnology
University of New Hampshire
Bachelor of Science - Biology
Plymouth State University