Interested in becoming a part of cutting-edge technology and opportunity? Does the idea of developing, manufacturing and marketing nuclear pharmaceutical drugs interest you? Then check out Zevacor Molecular at [link]. Zevacor is a rapidly growing, Indianapolis based radiopharmaceutical company producing drugs used for the diagnostic imaging of cancer and cardiovascular disease. We are affiliated with a $500 Million, 2200 employee healthcare system.
We are looking for an analytical chemist experienced in method development and cGMP within the pharmaceutical industry. The successful candidate will have good interpersonal abilities with particularly strong written communication skills. A BA/BS in biochemistry or chemistry is required. Three or more years of experience working in the pharmaceutical industry with adherence to cGMP is preferred. The candidate will be based in Indianapolis. Significant travel to various drug production facilities located throughout the U.S. is required
This person will be a key participant in the development and submission of Abbreviated New Product Applications (ANDAs) and Investigatory New Drug Applications (INDs). He or she will work closely with a team of people, including nuclear pharmacists and production technicians on site, as well as contracted experts in cyclotron and drug synthesis manufacturing. The objective of this team will be to commission, qualify, and operate radioactive drug production activities for a portfolio of generic or investigatory new drugs under 21 CFR Part 211 or Part 212. He or she will be responsible for developing the methods for conducting QC protocols on PET drug products. This person must be experienced working with a variety of chemistry and biochemistry analytical systems used for testing chemicals, reagents, precursors, and final drug products; such as Gas Chromatography, Ion Chromatography and HPLC Analyzers among others. Once commissioned, this person will be actively involved in supporting the production team to ensure that the QC equipment is properly maintained, calibrated and qualified.