Duties and Responsibilities:
• Supervise and conduct the development and validation of production methods for new diagnostic and therapeutic radiopharmaceuticals for Progenics Pharmaceuticals, Inc.
• The incumbent will supervise and support the manufacturing of radiopharmacenticals under GMP.
• The incumbent will be the onsite QA responsible person to review and approve the production batch records.
• The incumbent will make sure the released batches meet clinical and commercial demand, and that these radiopharmaceuticals are in full compliance with all regulatory requirements.
• The incumbent will also be the onsite Radiation Safety Officer supervising the safely handling of radioactive materials and train technicians based on NRC requirements.
• PhD degree in a scientific related discipline (e.g. Chemistry, biology, pharmaceutical science).
• Minimum of 5 years of experience with organic synthesis of compounds, analytical chemistry or radiochemistry. Priority will be given to candidates with significant experience with the production of I-131 or other radiopharmaceuticals for human use (under NDA, ANDA or IND) and experience with production using automated synthesis units for radiopharmaceuticals.
• Experience with quality control for identity and quantization such as High-Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC), Liquid Chromatography/mass spectrometry (LCMS), gas chromatography (GC), and Charles River Limulus test for apyrogenicity. Ability to trouble-shoot instrument malfunctions is highly desired.
• Knowledge of safety procedures for working in a hazardous environment (chemical and radioactive) as demonstrated through prior laboratory experience.
• Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification preferred.
• Knowledge of gamma spectroscopy, alpha spectroscopy, liquid scintillation and gas-proportional counting instrumentation.
• Understands chemistry manufacturing and controls (CMC) documentation for novel compounds consistent with requirements for IND, NDA, ANDA, RDRC or other regulatory pathways.
• Experience in a supervisory role is preferred.