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נקבה
נשואה
****
מלאה
חודשיים
תואר ראשון, תואר שני, דוקטורט
עברית
אנגלית
ערבית
רכב פרטי – רישיון ב'
רכב פרטי
2010-2005:Ph.D. בכימיה אורגנית, אוניברסיטת תל-אביב. סיום בהצטיינות.
מחקר: מטבוליים משניים ממקורות ימיים: בידוד וקביעת מבנה, בהנחיית פרופ' יואל קשמן.
2005-2003:M.Sc, במדעי הרוקחות, התמחות בכימיה תרופתית, אוניברסיטת העברית, ירושלים. סיום בהצטיינות.
2003-1999:B.Sc, בכימיה תרופתית, אוניברסיטת בר-אילן, סיום בהצטיינות.
מבין הקורסים: כימיה תרופתית | פרמקולוגיה בסיסית | וקורסים בביולוגיה.
השכלה
דיפלומה
הלימודים כללו מספר קורסים מבית הספר לרוקחות ורפואה בעין כרם בירושלים. מחקר: חקר תצמידים מרחביים של פולי (חומצה לקטית) ופפטיד בשימוש ברפואה, בהנחיית פרופ' אבי דומב.
2005: קורס CRA, מכללה ביו-רפואית.
שירות צבאי
ללא
EXPERIENCE:
2018 – present: Bar-Magen LTD (Animal Nutrition Solutions)
Quality & Laboratory Manager
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Led QC and analytical R&D lab operations, increasing throughput and improving on-time test delivery by 15%.
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Supported development and production of coated delayed-release products via QC testing, accelerating troubleshooting and reducing analysis cycle times.
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Implemented quality systems (SOPs, CAPA, RCA) to cut deviations and strengthen compliance and audit readiness.
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Drove process validation, method qualification, and data integrity, enhancing consistency and confidence in product and COA release decisions.
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Introduced advanced analytical technologies and optimized workflows, significantly reducing turnaround time.
2012-2018: Taro Pharmaceutical Industries (Haifa)
Development Expert
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Supported ANDA (formulation product) development strategy by executing scientific reviews, IP assessments, and gap analyses, aligning regulatory compliance and reducing submission risk.
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Authored and organized FDA-aligned technical & chemical documentation (batch records, reports/protocols) strengthening data integrity and traceability improving audit readiness, and accelerating internal approvals.
Senior R&D Researcher
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Led end-to-end development and optimization of 4 API processes using cGMP-aligned design and QbD/DoE, enabling scalability, robustness, and timely tech transfer.
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Drove root-cause investigations and troubleshooting with analytical tools, stabilizing processes, cutting impurities/delays by 30%, and improving throughput.
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Collaborated cross-functionally to implement CAPAs, SOPs, and GMP onboarding, enhancing execution quality and reducing deviations/OOS.
PROJECTS & ACHIEVEMENTS:
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Delivered FDA-DMF approvals for API processes accelerated development timelines by 30% and reducing manufacturing deviations through data-driven optimization and quality of design methodologies.
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Built and implemented end-to-end Quality system (QMS, SOPs, ISO 17025, Audit, CAPA), achieving a 35% reduction in deviations, regulatory compliance, and increased customer and regulator confidence.
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Enabled operational efficiency and business growth by integrating advanced analytical technologies, laboratory automation, and ERP workflows and green chemistry and improved customer satisfaction.
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Drove a Six Sigma operational excellence program to improve inventory control and workflow efficiency across the R&D department and applying ELN for experiment records.
CERTIFICATIONS & COURSES:
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Medical Device Quality, Regulatory Risk Management (ISO 13485 & 14971; FDA & EU MDR), Gstudy (2025)
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AI Strategies for Directors, Hebrew University of Jerusalem (2025)
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Validation of analytical methods, Bio-forum (2024)
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Introduction to MS- spectrometry- Bio-forum (2021)
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Efficient laboratories- Bio-forum (2020)
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Chem. Develop. & scale up in pharmaceutical industry -Academy Scientific Update (2017)
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Physical properties and characteristics of polymorph for pharmaceutical application- Bio-forum (2013)
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Clinical Research Associate (CRA) -Biomedical College (2005)
EDUCATION:
Postdoctoral Research Flew in Natural Products, Chemistry Department, Tel Aviv University (2011-2012)
Research Title: Chemical modifications for secondary metabolites from Fascaplysinopsis sp. sponge to enhance the biological activity, Prof. Yoel Kashman & Prof. Drorit Numan
Ph.D. in Natural Products, Chemistry Department in Tel Aviv University (2005-2009)
Thesis Title: Secondary metabolic sources: Isolation and construction, Prof. Yoel Kashman.
M.Sc. in Pharmaceutical Science, School of Pharmacy, Hebrew University of Jerusalem (2003-2005)
Thesis Title: Exploring stereo-complexes of poly-lactic and peptide in the use of medicine, Prof. Avi Dumb
B.Sc. in Medicinal Chemistry, Chemistry Department in Bar-Ilan University (1999-2003)
