Scientist, Process Chemistry
Newark Metro Area, NJ
A global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover 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.
The candidate must either be a US citizen or hold a green card.
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.