Gilli Rosenzweig
Product Quality @Prime Medicine, Inc.
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WORK HISTORY
Product Quality @Prime Medicine, Inc.
Cambridge, MA, US
EDUCATION
Technion - Israel Institute of Technology
Master of Business Administration - MBA, MBA, with emphasis on Management of Technology-Based Firms
Technion - Israel Institute of Technology
B.Sc. (Cum Laude), Biotechnology & Food Engineering
ASQ CQE
CQE (Certified Quality Engineer), ICQE (Israeli Certified Quality Engineer)
SKILLS
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
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