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.