Quality Control Lead

Overview

Join the best radiopharmaceutical company in the world!

If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, North Star Medical Radioisotopes is the place to do it. North Star Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.

At the forefront of North Star’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission—advancing life‑saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world‑class facilities and a competitive benefits package.

The primary role of this position is to conduct and validate various biological and analytical quality control assays associated with the processing of radiopharmaceutical isotopes and drugs to ensure compliance with established standards. This role requires extensive training on radiation safety including ALARA (“as low as reasonably achievable”) principles.

Projects and duties will be completed in compliance with applicable regulatory agency standards.

This position supports production in a 24‑hour manufacturing facility which means your schedule provides days off during the week when weekend work is required. Early morning, late evening, weekend, and some holiday work will be required with occasional overtime.

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Lead, coordinate, and communicate QC Team responsibilities and activities.
• Provide on the job training for QC team and assist in trouble shooting analytical instruments.
• Proficiently operate analytical instrumentation.
• Perform company‑wide training and facilitate training program for QC personnel on industry best practices for ISO controlled environments.
• Author, review, and approve quality test data, protocols, reports, SOPs.
• Assist with the transfer of validation activities of Quality Control (QC) test methods.
• Serve as the subject matter expert in analytical instrumentation.
• Participate independently as the lead on multiple projects and meetings.
• Support the department manager and/or designee in their absence.
• Initiate and approve non-conforming materials reports (NCMRs), investigate deviations, laboratory out‑of‑specification (OOS), and CAPA investigations. Perform risk assessments, participate in root cause analysis investigations, tracking, follow‑up, and reporting/trending.
• Participate in internal assessments and regulatory audits as required.

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories
• Trained on ALARA principles and RAD safety
• Provide support to site operational readiness
• Start training on final product testing and batch processes

After 6 months you will:

• Be qualified on more advanced analytical techniques such as HPLC
• Be proficient in the majority of QC batch release activities
• Support tech transfer, stability, and product validation testing
• Be qualified to provide training to other team members on certain QC functions

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and minimum nine (9) years of experience in a regulated industry; or equivalent combination of education and experience. Preferred qualifications include:

• Nine (9) years of related experience in a cGMP environment and previous experience handling radioactive materials preferred.
• Understanding of pharmaceutical manufacturing processes.
• Familiarity with alpha, gamma, and beta spectroscopy is a plus.

Please note the company cannot provide immigration‑related sponsorship (including H‑1B status, O‑1 status, Optional Practical Training support, etc.) for this position. Each…