Job Information
Chartwell Pharmaceuticals, LLC Vice President, R&D (Research and Development) in Congers, New York
Duties: Research and develop prescription medicines which include brand and generic formulations. Perform technical transfer of approved Abbreviated New Drug Applications which are bioequivalent to brand Products. Review Technical specifications for active pharmaceutical ingredients and Excipients. Review Product dossiers. Review clinical data. Review analytical data and evaluation. Review, edit, and approve technical documents (Batch manufacturing & packaging Records, Protocols, Site Transfer reports). Review Product stability and evaluation. Perform troubleshooting of any problems or issues arising from the manufacturing of prescription medicines. Address queries from the U.S. FDA (Food and Drug Administration) related to research, development, and site transfers of approved pharmaceutical products. Perform Technical assessment and evaluation of future pharmaceutical product portfolio. Minimum requirements: Master’s Degree in a Pharmaceutical field (including Pharmaceutics, Pharmaceutical Science, or Pharmaceutical Science and Technology) plus 3 years of experience in the job offered.Required skills: Must have experience using the following skills: Pharmaceutical Product research and development; Technology transfer; development/transfer of Pharmaceutical formulations/products; review of technical documents including in-process and finished product specification, product development reports, scale-up reports and technical transfer reports; using quality by design (QbD); conducting experiments execution using software tools, including Design Expert, and working with issues involving Pharmaceutical regulation, intellectual property rights pertaining to Pharmaceutical products and clinical research.
Minimum Salary: 264,600 Maximum Salary: 264,600 Salary Unit: Yearly