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 HR@spectronrx.com.