PROCESS ANALYTICAL ENGINEER, MATERIAL SCIENCE AND ENGINEERING TECHNOLOGY, DRUG PRODUCT DEVELOPMENT
Newark Metro Area, NJ
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.