Sr. Quality Control Chemist I; Isotope Production

Role Summary

Sr. Quality Control Chemist I, Isotope Production. Operates in a GMP environment performing analyses on radiometals and radiopharmaceuticals, supporting technology transfer, and ensuring laboratory compliance with safety and quality standards. Works with production teams to schedule testing, assists in SOP development, and provides technical support to internal and external stakeholders. This is a first-shift, salaried role with potential for additional hours and travel.

Responsibilities

• Perform analyses on radioisotopes (radiometals) using ICP-MS, HPGe, radiochemical TLC, and related methods; HPGe experience is desirable.
• Assist in technology transfer of analysis methods for radioisotope production.
• Coordinate testing with production teams based on manufacturing needs; analyze finished radiopharmaceutical products as needed.
• Assist in writing and reviewing laboratory SOPs and related documents.
• Calibrate and maintain laboratory equipment; support qualification and maintenance activities; onboard new instrumentation as required.
• Troubleshoot analytical issues, identify root causes, and implement corrective actions.
• Develop and maintain documentation, particularly data analysis.
• Ensure GMP, safety, and quality compliance; collaborate with Radiation Safety Officer to maintain radiation safety programs.
• Provide technical support to other teams and vendors; support installation and qualification of laboratory equipment in GMP environments.
• Mentor junior chemists as needed.
• Travel up to 10% may be required; other tasks as assigned by management.

Qualifications

• Required: Minimum BS in Chemistry or related field with 5+ years of pharmaceutical or radioisotope experience; or MS in Chemistry with 3-7 years of relevant experience.
• Required: Experience handling radioactive materials; experience testing in a quality control chemistry lab.
• Preferred: Experience with radiopharmaceuticals or radioactive isotopes; familiarity with actinide elements and alpha emitters; GMP knowledge/experience; proficiency with root cause analysis techniques (6 M's, 5 Why's, fishbone, etc.).

Skills

• Strong radiation safety culture and clear communication with internal/external stakeholders.
• Independent, organized, and able to work in a multidisciplinary GMP environment; capable of multitasking and prioritizing across multiple workflows.
• Proficient with Microsoft Office and chromatography systems; maintains high professional ethics and confidentiality.

Education

• BS in Chemistry or related field (required if not using MS path); MS in Chemistry or related field (alternative path with fewer years of experience).

Additional Requirements

• Travel up to 10% may be required.
• Laboratory environment with protective clothing, gloves, and safety glasses; work with radioactive materials.