Perform formulation and process development of solid and/or liquid dosage forms including manufacture of laboratory and pilot scale lots. Coordinate and observe Registration Lot manufacture in the plant. . Develop product and process specifications interpreting physicochemical data and conducting studies to insure that the product is manufacturable stable and bioequivalent to the brand. Additional responsibilities include preparing documentation to support ANDA filings.
Interface with other departments to accomplish goals with no direct supervision. Mentor/supervise technicians and/or contract personnel. Understand bioequivalence study requirements and strategies for ANDAs. Prepare technical reports and other documents required by cGMPâ€™s and laboratory policies for regulatory filings.
• Four (4) to eight (8) years of formulation development experience in the Pharmaceutical Industry and hands on experience in development and evaluation of multisource pharmaceutical dosage formulations processes and equipment is required
• Capacity for independent work requiring attention to detail with scientific judgment and professional competency. Ability to work intra- and interdepartmentally using a team approach to accomplish tasks assigned. Must possess the ability to manage multiple projects in a fast moving dynamic environment.
• Behaviors required for the following associated responsibilities include good oral and written communication skills ability to develop others ability to build strategic working relationships and strong technical and professional knowledge.
• EDUCATION: Ph.D. in Pharmaceutics or related science or M.S. in Pharmaceutics or related science
• JOB DURATION: This job is full time..
• COMPENSATION RANGE: 0/yr
Biological-Chemical Research, Biotechnology and Pharmaceutical