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Reference # : 18-01390 Title : Process Analytical Engineer
Location : Summit, NJ
Position Type : Contract
Experience Level : Start Date / End Date : 06/11/2018 / 06/15/2019  
Attention Vendors: correct title is: PROCESS ANALYTICAL ENGINEER, MATERIAL SCIENCE AND ENGINEERING TECHNOLOGY, DRUG PRODUCT DEVELOPMENT, please provide it and the JD to the candidates.

Client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to Client and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence, and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science, and contribute to our unique culture.

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

Skills/Knowledge Required:

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.

Client is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Client complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Client in the U.S.