Claire Pasquinelli
VP, CMC Program Management
- Role
- VP, Cmc Program Management at Kriya Therapeutics, Inc.
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Claire Pasquinelli
Experienced in technology transfer, project management, pharmaceutical manufacturing, investigations, business process definition and creation. Self-motivated professional manager, capable of leading people, working independently and as a team. Technical and project leadership experience, able to master new skills quickly. Project and Personnel Management - Adept with project management tools, including project scheduling, metrics, and centralized communication tools- Skilled meeting organizer and facilitator with the ability to overcome organizational boundaries to accomplish goals- Proficient with various process improvement and Risk Management methodologies at different stages of the product development lifecycle, including Process Mapping, Root Cause Analysis, Failure Mode and Effects Analysis (FMEA)- Skilled at problem solving, team building, maintaining business knowledge, developing talent, and business process developmentIndustry-Specific- Proficient with biologics manufacturing from development through full scale pharmaceutical manufacturing (clinical & process validation), experienced with cGMP compliant manufacturing- Familiarity with regulatory guidelines pertaining to the biopharmaceutical industry, including process validation, lifecycle management, and submission requirements for biopharmaceuticals.
Experience
VP, Cmc Program Management
Apr 2025 — Present · Raleigh-Durham-Chapel Hill, NC, US
Education
North Carolina State University
M.S., Chemical Engineering
2008 — 2010
North Carolina State University
B.S., Biological Engineering
2002 — 2006
Skills
- Process Analysis
- Biotechnology
- Process Engineering
- Protein Purification
- Manufacturing
- Fda
- Glp
- Process Development
- Ultrafiltration
- Fermentation
- Process Simulation
- Gmp
- Technology Transfer
- Corrective Action
- Troubleshooting
- Biopharmaceuticals
- Corrective Actions
- Filtration
- R&D
- Technical Writing
- Chemical Engineering
- Cgmp
- Protein Chemistry
- Purification
- Investigation
- Chromatography
- Downstream Processing
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