| PD Scientist I, Ohm Laboratories, Inc., New Brunswick, NJ. Design experimental plans, execute studies for routine development, scale-up/s and exhibit batches. Analyze data and perform root cause analysis in trouble shooting. Formulate and design drug products using QbD methodologies. Assist in the transfer of site transfer and technology transfer projects. Participate in manufacturing of scale-up and Submission Batches. Prepare reports on project status, literature review, and technical issues and their resolution affecting the product development. Prepare product and process development reports. Stay current on regulatory and industry changes. 40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. MINIMUM REQUIREMENTS: Master’s degree or foreign equivalent in Pharmaceutical Science or a related field, and 4 years of related work experience. Must have 4 years of experience with/in: - Product development, tech transfer, site transfer, process development and/or manufacturing; - Utilizing knowledge of CGMP’s, FDA, DEA and OSHA regulations; - QbD methodologies; - Applying knowledge of pharmaceutical operations, including: Tableting, particle coating for controlled or targeted release applications, encapsulation and fluid bed operation; and, - Working with manufacturing, quality control, management personnel, customers, outside vendors and suppliers in a pharmaceutical environment. To apply, mail resume to Jay Patel, Human Resources referencing NJ0002 to 2 Independence Way, Princeton, NJ 08540. |
