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Newark Metro Area, NJ

Posted: 05/17/2018 Job Type: Scientific Job Number: JN -052018-21611
This position is responsible for establishing Process Analytical Techonology (PAT) methods for process development, characterization, optimization, scale-up, and technology transfer activities of small molecule drug products (DPs) for clinical development of new pharmaceutical products.

Responsibilities will include, but are not limited to, the following:

o Apply material characterization and process analytical expertise to evaluate the composition, structure, and properties of pharmaceutical systems. Perform data analysis and interpretation.
o Work with product and process development teams to provide critical data needed to commercialize new technologies, optimize or enhance existing products or processes.
o Evaluate and recommend adoption of new PAT technologies for process characterization, understanding and improvement.
o Support PAT method development, validation, transfer and implementation.
o Provide technical consultation as needed to product technology, manufacturing, and commercial teams to support new growth programs and production optimization efforts.
o Maintain a productive laboratory workspace, which includes managing workflows, processes and systems for the lab, maintaining / troubleshooting equipment, and provide recommendation for continuous improvement.

Hold a scientific or engineering degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Material Science, Analytical Chemistry or related fields.
Ph.D. with 0-2 years, or M.S. with minimum of 4 years, or B.S. with minimum of 6 years of pharmaceutical, chemical or analytical development experience

o Hands-on technical expertise with effective instrument operation and maintenance, and strong theoretical understanding in one or more of the following fields is required:
Spectroscopy (FTIR, NIR, Raman) with chemometric data analysis.
Material / Pharmaceutical/ Separation Science
Process Analytical Technology
Statistical data analysis and multivariate data analysis
o Experience working in a GMP environment is a plus
o Programming experience with Matlab, S-PLUS, SAS and familiarity with commercially available chemometrics packages such as SIMCA-P, Unscrambler and Grams
o Self-motivation, excellent time management, organizational, written and oral communication skills.

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