senior radiochemist / radiochemist

SpectronRx has a great opportunity for BOTH a Senior Radiochemist and a Radiochemist at our South Bend, Indiana facility. Each position  will be expected to perform the following responsibilities to differing degrees:

• Performing chemistry manipulations for production, QC, and other responsibilities in      a GMP environment to meet manufacturing schedules.
• Implement analytical methods and procedures for QC testing of GMP manufactured      radiopharmaceutical products.
• Optimize and validate QC methods and procedures for radiopharmaceutical products.
• Execute material transfer and technology transfer agreements
• Equipment purchase, implementation, and maintenance, as needed
• Oversee implementation of radiation safety standards and policies
• Management and oversight of clean room, including training, cleaning, maintenance, monitoring, validation and routine qualification, and supply chain management
• Oversight, execution, documenting and reporting of environmental monitoring
• Ensure regulatory compliance of production and QC protocols within the      manufacturing operations.
• Assist with creating SOP’s for use in production, QC and continuous process      improvement.
• Prepare and submit required reports.
• Assist with the preparation of regulatory submissions.
• Meet with regulatory officials as needed to support submission approvals
• Support and execute deviation reports, OOS, root cause investigations, and CAPA.
• General staff responsibilities for lab cleaning, supplies and maintenance.

*The above represent the minimum job expectations and are subject to change.

Qualified applicants will have: 

• A Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering or a related field. An Associates’ Degree in these areas, along with a minimum of 3 years of related experience in a pharmaceutical manufacturing environment (including radiopharmaceutical experience) may be considered.
• Requires a minimum of 2 years of prior experience in pharmaceuticals, preferably in a radiochemistry position. Prior experience in a radiopharmaceutical environment is required.
• Excellent communication, analytical, computer/pc and technical writing skills.
• The ability to handle responsibilities in a fast paced manufacturing environment.
• Great attention to detail, and excellent communication skills.
• Demonstrated ability to work as part of a team.
  

We offer a competitive compensation & benefits package. Join a company on the move!

Must be authorized to work in the U.S.

Please send your CV to HR@spectronrx.com.