Melissa Darnley
Scientist | MSc | Quality Control | Excited for New Opportunities in Regulatory | Attention to Detail
- Role
- Qc Data Reviewer Ii at Sarepta Therapeutics
- Location
- Medford, MA, US
- LinkedIn followers
- 500 followers
Experience
Qc Data Reviewer Ii
May 2024 — Present · Andover, MA, US
Review protocols, testing, reports, and CoA/ToTs for release and stability of AAV based gene therapy products Monitor, compile, and review analytical and QC data individually and with team members Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents Support the method development, transfer and qualification/validation activities associated with the release of bacterial plasmids, viral vector products, critical reagents, and reference material Assist in necessary lab work to support ongoing projects managed by the QCTS team Trend data for qualified materials, release products, and stability products Assist in writing and reviewing quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites Act as company liaison with CMOs to coordinate in method development, method transfer, and release and stability testing across various CMO/CRO sites as needed Author regulatory reports to summarize results of stability testing for various pipeline projects
Education
Tufts University
Master's degree, Infectious Disease and Global Health
2015 — 2016
Wheaton College Massachusetts
Biology, Pre-Medicine/Pre-Medical Studies
2010 — 2014
Skills
- Powerpoint
- Research
- Critical Thinking
- Hardwork
- Photoshop
- Teamwork
- Biology
- English & Spanish Languages
- Taekwondo
- Tissue Culture
- Microsoft Office Suite
- Laboratory Inventory Management System Software
- Whole Slide Digital Scanning
- Advanced Digital Image Analysis Algorithms
- Spss
- Adobe
- Immunohistochemistry
- Aseptic Technique
- Pcr
- Gel Electrophoresis
- Primary Tissue Culture Harvesting
- Protein Purification
- Differential Centrifugation
- Rt-Pcr
- Dna Cloning
- Protein Expression
- Flow Cytometry
- Viral Plaque Assays
- Sds-Page
- Cell Cytotoxicity
- Cell Culture
- Elisa
- Immunofluorescence
- Gas Chromatography
- Western Blotting
- Site-Specific Mutagenesis
- Pipetting
- Plating
- Enzyme Assays
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.