Kelly Levasseur
- Role
- Sr Manager Qc Stability, Technical Operations at Invivyd
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Kelly Levasseur
Experienced technical professional with demonstrated success in project management…
Experience
Sr Manager Qc Stability, Technical Operations
Apr 2021 — Present
Establish, oversee, update, and maintain drug substance and drug product stability programs, including oversight of external laboratories • Author stability sections of regulatory filings (key contributor to IND, IMPD, EUA submissions) and assist with responses to inquiries from health authorities • Assign and extend shelf-life of drug substance and drug product, ensuring there are no interruptions in clinical trials • Author stability reports and Annual Product Reviews for products • Ensure timely initiation of stability studies and that they meet ICH guidelines • Create data tables, perform trending analysis of data, and facilitate timely investigation of out-of-specification/out-of-trend result occurrences • Initiate and manage Change Controls for stability related activities • Provide technical and documentation support as the Stability SME, and present regular stability updates to Technical Operations and Quality groups • Collect and present meaningful stability metrics internally and externally for QMR, and contribute to process improvements • Author and review Stability and Shelf-Life SOPs and Forms • Facilitate stability sample identification and transfers when needed to aid development testing • Participate in the establishment of drug substance and drug product specifications • Provide stability assessments as needed for product temperature excursions
Skills
- Quality System
- Continuous Improvement
- Gap Analysis
- Protein Purification
- Cmos/Cros
- Stability
- Quality Assurance
- Expiry
- R&D
- Proteomics
- Quality Control
- Lims
- Change Control
- Regulatory Submissions
- Fda/Ich Guidelines
- Sigmaplot
- Track/Trend Data
- Contract Labs
- Purification
- Editing
- Edocs
- Html/Web Design
- Sds-Page
- Visio
- Cancer
- Gmp
- Protein/Peptide N-Terminal Sequencing
- Project Management
- Biotechnology
- Hplc
- Sharepoint
- Lotus Notes
- Biochemistry
- Technical Writing
- Elisa
- Glp
- Protein Chemistry
- Immunoassays
- Amino Acid/Hexosamine Composition
- Assay Development
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