Radiopharmaceutical Production Chemist II: GMP & Process Lead

SOFIE; Totowa (NJ); On-site; USD 85,000 - 90,000; Full time

Job summary

SOFIE in Totowa, NJ, seeks a Pharmaceutical Production Chemist II to support the production of radiopharmaceuticals under GMP and 21 CFR 211. You will operate automated equipment, lead process transfers, and ensure regulatory compliance.

The role requires collaboration with partners and adherence to hazardous materials safety guidelines. Responsibilities include equipment maintenance, batch processing in cleanrooms (ISO-7/ISO-5), deviation reporting, SOP and validation work, and packaging

Qualifications

• Bachelor’s degree in Chemistry, Biology, or Physical Science with 2+ years of radiopharmaceutical manufacturing experience.
• GMP manufacturing environment experience required.
• Experience with automated synthesis modules preferred.
• Ability to read and interpret safety and procedure documents required.
• Knowledge of cGMP, aseptic processes, and equipment qualification required.
• Proficiency with MS Office.
• Detail-oriented and able to work with minimal supervision; HAZMAT/Radiation Worker compliance experience preferred.
• Ability to work multiple shifts; travel 10%.

Responsibilities

• Operate, maintain, and report process data from automated and semi-automated radiopharmaceutical manufacturing equipment.
• Prepare materials/consumables for manufacturing processes and perform system checks on equipment before use in aseptic processes.
• Perform manufacturing activities in ISO-7 and ISO-5 environments.
• Follow detailed instructions in Master Batch Records and report deviations.
• Lead and organize production operators on technology transfer of processing (synthesis) for sterile drug manufacturing.
• Lead and execute qualification/validation campaigns for new radiopharmaceutical processes.
• Prepare SOPs and validation protocols for production processes and equipment.
• Package manufactured drug product for shipment to clinical sites.
• Maintain radiation safety compliance and provide related training as required.
• Attend meetings and participate in investigations, CAPAs, and Change Control related to manufacturing.

Skills

GMP experience

Radiopharmaceuticals

Team collaboration

Attention to detail

Education

Bachelor’s degree in Chemistry, Biology, or Physical Science

Tools

Automated synthesis modules

Job description

SOFIE in Totowa, NJ, seeks a Pharmaceutical Production Chemist II to support the production of radiopharmaceuticals under GMP and 21 CFR 211. You will operate automated equipment, lead process transfers, and ensure regulatory compliance.

The role requires collaboration with partners and adherence to hazardous materials safety guidelines. Responsibilities include equipment maintenance, batch processing in cleanrooms (ISO-7/ISO-5), deviation reporting, SOP and validation work, and packaging