Laura Pack
Head of CMC Quantitative Sciences
- Role
- Head of Cmc Quantitative Sciences at Moderna
- Location
- Franklin, MA, US
- LinkedIn followers
- 500 followers
About Laura Pack
Skilled CMC professional with comprehensive experience in clinical and commercial product programs. Proven ability to explain highly technical subject matter to diverse scientific and professional audiences. Experience leading cross-functional teams and negotiating with senior leadership to develop standardized business practices that support strategic objectives and science-based decisions. Practiced in using statistical analysis to make objective, data driven quality decisions in a complex and highly regulated biopharmaceutical environment.
Experience
Head of Cmc Quantitative Sciences
Feb 2024 — Present · Norwood, MA, US
Education
University of Colorado Boulder
Bachelor's Degree, Chemistry, Biochemistry
1996 — 2003
Colorado State University
Master's Degree, Applied Statistics
2013 — 2016
Colorado State University
Certificate, Applied Statistics
2007 — 2009
Skills
- Corrective and Preventive Action (Capa)
- 21 Cfr Part 11
- Medical Devices
- Trend Analysis
- Capa
- Control Charts
- Change Control
- Pharmaceutical Industry
- Sop
- Fda
- Laboratory Information Management System (Lims)
- Lims
- Biopharmaceuticals
- Stability Programs
- Product Quality
- Data Analysis
- Product Launch
- Quality Control
- Gmp
- Glp
- Process Optimization
- Standard Operating Procedure (Sop)
- U.s. Food and Drug Administration (Fda)
- Stability Testing
- Statistics
- Quality System
- International Expansion
- Biotechnology
- Stability
- Life Sciences
- Quality Assurance
- Cross-Functional Team Leadership
- U.s. Title 21 Cfr Part 11 Regulation
- Statistical Data Analysis
- Regression Analysis
- Validation
- Shelf Life
- Technology Transfer
- Project Management
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