Process Scientist - PAT
Edison-New Brunswick Metro Area, NJ
- PROCESS ANALYTICAL ENGINEER, MATERIAL SCIENCE AND ENGINEERING TECHNOLOGY, DRUG PRODUCT DEVELOPMENT,
- Requirements: 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
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.
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
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.