Process Analytical Engineer
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 process analytical technology (PAT) and material characterization expertise to evaluate the composition, structure, and properties of pharmaceutical systems. Perform data analysis and interpretation.
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.
o Hands-on technical expertise on PAT and Spectroscopy tools (including but not limited to FTIR, NIR, MIR, Raman, etc) with effective instrument operation and maintenance, and strong understanding in:
Statistical, Multivariate and Chemometric data analysis
Material / Pharmaceutical/ Separation Science
o Working knowledge of key pharmaceutical unit operations both in drug substance and drug product including, but not limited to, crystallization, mixing, milling, granulation (wet and dry), tablet compression, and coating. Laboratory hands-on experience. Big data interpretation, manuscript preparation, publication and presentation of results.
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
o Self-motivation, excellent time management, organizational, written and oral communication skills.
Hold a chemical, mechanical, material science, pharmaceutical science degree, 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