SOFIE
Little Falls, NJ, USA
Title | Senior Product Development Specialist Position Note | OPEN to any SOFIE locations Location | Totowa, NJ Department | Radiopharmaceutical Contract Manufacturing (RCM) Reports To | Director, Radiopharmaceutical Contract Manufacturing (RCM) OVERVIEW The Senior Product Development Specialist will lead the development, implementation, and validation of manufacturing and analytical methods of new diagnostic and therapeutic radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Working closely with SOFIE’s pharmaceutical partners, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and 212). ESSENTIAL DUTIES AND RESPONSIBILITIES § Develop protocols for the production and analysis of clinical-grade radiopharmaceuticals, validate these methodologies against quality...