Gilli Rosenzweig

Product Quality @Prime Medicine, Inc.

Cambridge, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2023 — Present

Product Quality @Prime Medicine, Inc.

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Cambridge, MA, US

EDUCATION

2006 — 2009

Technion - Israel Institute of Technology

Master of Business Administration - MBA, MBA, with emphasis on Management of Technology-Based Firms

2000 — 2004

Technion - Israel Institute of Technology

B.Sc. (Cum Laude), Biotechnology & Food Engineering

2012 — 2012

ASQ CQE

CQE (Certified Quality Engineer), ICQE (Israeli Certified Quality Engineer)

SKILLS

Project ManagementAnalytical ChemistryGxpPharmaceuticsStart-Up VenturesLife SciencesQuality SystemQuality SystemsLaboratoryBiopharmaceuticalsRegulatory SubmissionsLeadershipTeam LeadershipProfessional ResponsibilityStrategic PlanningProduct DevelopmentTechnology TransferClinical TrialsQuality AssuranceEntrepreneurship21 Cfr Part 11CapaChange ControlStrategic PartnershipsGlpPharmaceuticalsStrategyValidationLaboratory Information Management System (Lims)Process ImprovementGmpPharmacologyCell CultureBiotechnology IndustryRegulatory AffairsLifesciencesCross-Functional Team LeadershipBiotechnologyResearch and Development (R&D)R&D

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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