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Product Development Technical Support

Location:
New Jersey, United States
Posted:
January 22, 2018

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Natalie Garber

Colonia, NJ ***** Cell: 908-***-**** Home: 732-***-**** ac342k@r.postjobfree.com

OBJECTIVE

To secure an analytical chemist position in pharmaceutical product development. SUMMARY

Research Scientist with 19 years experience in Dry Powder and Metered Dose inhalation/respiratory product development.

• Knowledge of aerosol performance testing, including cascade impaction (e.g., Next Generation Impactor, Andersen Cascade Impactor, and Automated Andersen Cascade Impactor System).

• Extensive experience in the research, development and validation of analytical and physicochemical methods using Chromatography and Spectroscopy techniques.

• Proficient in project management within cross-functional teams to meet timelines with high quality deliverables.

• Strong capabilities in problem-solving, learning speed, and innovative thinking.

• Excellent communication skills in technical writing, presentations, and team discussions. PROFESSIONAL EXPERIENCES

Teva Pharmaceuticals Ewing, NJ 2014-Present

Analytical Chemistry Scientist III (Contractor)

Provided analytical support for development of a novel active dry powder inhaler (DPI) and Dry Powder and Metered Dose formulations following CFR Part 11 and ISO regulations for combination products.

• Supported analytical method development for inhalation projects with aggressive time lines.

• Evaluated formulations and a novel dry powder inhaler performance by means of the aerodynamic particle size distribution (APSD) by NGI/FSI, Assay, Moisture, and DDU testing.

• Performed HPLC analysis for all ongoing studies in the most efficient manner.

• Summarized and reviewed results, wrote reports.

• Assumed a responsibility as SME for the Global NuGenesis Production ELN Respiratory implementation in Teva Ewing site.

Merck & Co., Inc. (legacy Schering-Plough Corporation) Summit, NJ Senior Scientist (Merck Research Labs/Respiratory Product Development) 2010- 2013 Led analytical support of a new project to develop established drugs for inhalation delivery (lifecycle management).

• Participated in development of novel non-invasive aerosol delivery system for pre-clinical species.

• Developed a rapid high-throughput in vitro screening assay for predicting drug deposition pattern in respiratory tract that correlated with in vivo results.

• Implemented a novel APSD Abbreviated Impactor Measurement (AIM) technique for the pulmonary inhalation products testing.

• Supported technology transferring and consulting to improve delivery to lung in preclinical asthma pharmacodynamics (PD) model.

Supported development of unit dose DPI device platform.

• Performed APSD by ACI testing of DPI devices on different stages of modification.

• Analyzed the data and participated in discussions moving forward.

• Reported and presented scientific results internally/externally. Provided technical support to release and stability studies in a cGMP environment. Page 1 of 2

Associate Scientist, Scientist I, Scientist II (R&D/Inhalation Group) 2001-2010 Provided analytical support in Phase I, II, III, and IV clinical program for DPI and MDI platform.

• Developed and validated APSD by ACI, EDU, DCU, and Moisture Content analytical methods.

• Performed release and stability testing in a cGMP environment following Six Sigma and Quality by Design principles.

• Analyzed and interpreted results in written and oral format.

• Implemented LIMS/Empower interface increasing efficiency of the data transfer, calculation and review of the results.

• Investigated and analyzed Out of Specification results using the TrackWise data base. Identified the reasons and suggested ways to significantly decrease human error during laboratory testing.

• Wrote SOPs, ensuring compliance with a cGMP regulations.

• Authored reports and collaborated on data verification, and review in accordance with SOPs.

• Transferred analytical methods for Asmanex 100 mcg DPI testing to Schering Corp. Japan and CROs.

• Prepared the laboratory for internal/external audits and certification. Contributed to organizational development by actively participating in coaching and mentoring interns and entry-level scientists.

Assistant Scientist I, Assistant Scientist II 1998-2001 Provided analytical support to the Phase IV clinical program for Nasonex 50 mcg MDI product.

• Invented a process to improve the efficiency of the aerodynamic particle size distribution testing using ACI.

• Met highly aggressive project timelines for release and stability testing for MDI aerosol products in a cGMP environment.

• Assumed responsibility for calibration and maintenance of analytical equipment. EDUCATION

Master of Science, Organic Chemistry, Chemical Engineering and Technology Kharkov Polytechnic Institute, Kharkov, Ukraine

SOFTWARE EXPERIENCE

Data Acquisition Systems: Waters, PerkinElmer, Agilent Software Packages: Turbochrom, Chemstation, Millennium32, Empower 2, RLIMS (Research Laboratory Information Management System), LEI (RLIMS/ Empower Interface), TrackWise (Quality Tracking System), eLearning and Document Management Systems Page 2 of 2



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