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senior radiochemist / radiochemist

Job Description:

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