Duties and Responsibilities:
The Radiochemist will lead the development and validation of production methods for new diagnostic and therapeutic radiopharmaceuticals for Progenics Pharmaceuticals, Inc. The incumbent will work closely with our manufacturing partners to ensure smooth technology transfer and execution of the GMP production batches to meet clinical and commercial demand, and that these radiopharmaceuticals are in full compliance with all regulatory requirements.
1. Develop and validate the production protocols for the manufacturing of clinical-grade and commercial-grade radiopharmaceuticals.
2. Conduct regular production of radiopharmaceuticals for clinical use according to cGMP standards.
3. Perform Quality Control tests according to SOPs on radiopharmaceutical products (e.g. TLC, GC, sterility, bioburden).
4. Perform release testing according to SOPs on other materials (e.g. raw materials for radiopharmaceutical production).
5. Maintain accurate radiopharmaceutical production records and test/validation results.
1.PhD degree in chemistry with a minimum of 8 years of experience with organic synthesis of compounds or analytical chemistry. Priority given to candidates with experience with the production of I-131 radiopharmaceuticals and experience with production using automated synthesis units for radiopharmaceuticals.
2.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 Limulus test for apyrogenicity.
3.Knowledge of safety procedures for working in a hazardous environment (chemical and radiological) as demonstrated through prior laboratory experience.
4.Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required.
5.Knowledge of gamma spectroscopy, alpha spectroscopy, liquid scintillation and gas-proportional counting instrumentation.
6.Understands chemistry manufacturing and controls (CMC) documentation for novel compounds consistent with requirements for IND, NDA, ANDA, RDRC or other regulatory pathways.
7.Supervisory experience in an environmental testing laboratory is preferred.
Technical Skills Required:
1.Working knowledge of organic and analytical chemistry.
2.Working knowledge of radiochemistry.
3.Experience with automated equipment for synthesis and purification.
4.Ability to work independently and in a team with strong communication skills, including proficiency in English both written and oral.
5.Demonstrated ability to prioritize multitask and troubleshoot problems.
6.Demonstrated ability to readily acquire new skills and techniques.