Gilli Rosenzweig
Seasoned, Goals-Driven, Results-Oriented Quality Leader | Pharmaceutical, Biologics, Cell Therapy
- Role
- Product Quality at Prime Medicine, Inc.
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Gilli Rosenzweig
Experienced CMC and Quality leader with a passion for innovation. Offers CMC and quality management experience in global pharma and biotech settings. Has international management experience in leading early-stage projects and developing quality systems, superior adaptability to fulfill changing business needs.Possesses solid leadership, inclusive communication, and interpersonal skills. Prioritizes positive working relationships at all levels of staff and management.Strong science knowledge base and a solid technical understanding. Holds a B.Sc. in Biotechnology Engineering and an MBA from the Technion - Israel Institute of Technology.Skilled quality/compliance auditor with expertise in auditing biopharmaceutical bulk, fill/finish, and testing laboratories, as well as large-scale API and oral solid dose manufacturing operations globally.Core qualifications include:• Development and execution of quality requirements • Project management• GMP Audits at CMOs and vendors• Risk and Change Management• Quality oversight of GxP and GAMP systems • Analytical Method Validation and Quality Control• Bioprocess Characterization & ValidationKeywords: R&D - Early Stage - Leadership - Innovation - Operations - International - CMO - Batch Release - CMC - Problem solving - MBA -Quality Management - Project - Product - Management - Professional - Delivery - Sterile - Production - Injection - Biosimilar - Drug - Device - Regulation - Site transfer - Biotechnology - Bioprocess - Bio-Medical - Validation - Process - Engineering - Technology - Strategy - Compliance - Person-in-the-plant - Board - Metrics - Startups - Technology
Experience
Product Quality
Jun 2023 — Present · Cambridge, MA, US
Education
Technion - Israel Institute of Technology
Master of Business Administration - MBA, MBA, with emphasis on Management of Technology-Based Firms
2006 — 2009
Technion - Israel Institute of Technology
B.Sc. (Cum Laude), Biotechnology & Food Engineering
2000 — 2004
ASQ CQE
CQE (Certified Quality Engineer), ICQE (Israeli Certified Quality Engineer)
2012 — 2012
Skills
- Project Management
- Analytical Chemistry
- Gxp
- Pharmaceutics
- Start-Up Ventures
- Life Sciences
- Quality System
- Quality Systems
- Laboratory
- Biopharmaceuticals
- Regulatory Submissions
- Leadership
- Team Leadership
- Professional Responsibility
- Strategic Planning
- Product Development
- Technology Transfer
- Clinical Trials
- Quality Assurance
- Entrepreneurship
- 21 Cfr Part 11
- Capa
- Change Control
- Strategic Partnerships
- Glp
- Pharmaceuticals
- Strategy
- Validation
- Laboratory Information Management System (Lims)
- Process Improvement
- Gmp
- Pharmacology
- Cell Culture
- Biotechnology Industry
- Regulatory Affairs
- Lifesciences
- Cross-Functional Team Leadership
- Biotechnology
- Research and Development (R&D)
- R&D
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