Nuclear Pharmacist

Overview

Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.

NorthStar 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, and customized radiopharmaceutical development services.

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

Position

The Nuclear Pharmacist will handle radioactive materials within the scope of manufacturing and production of radiopharmaceuticals for clinical trials and commercial products. This role will act as the subject matter expert (SME) for radiopharmaceutical preparations, participating in routine operations and training operations staff accordingly. Responsibilities include equipment calibration, batch dissolution, product synthesis, dispensing of medical radioisotopes, and aliquoting of finished patient doses, while complying with procedures, instructions, and prescribed routines. The Nuclear Pharmacist will identify and troubleshoot issues, as well as recommend process improvements.

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

This position supports production in a 24-hour manufacturing facility, requiring weekend work. Early morning, late evening, weekend, and some holiday work will be required.

Responsibilities

• Operate as the SME across various aspects of radiopharmaceutical manufacturing including but not limited to the manufacturing of the drug intermediate and finished dose production processes.
• Assist in the accurate and timely preparation and completion of records related to manufacturing, including Batch Records, Forms, Log Books, etc.
• Demonstrate expert knowledge of radiopharmaceutical compounding and dispensing procedures by staying current with drug manufacturing regulations and requirements.
• Mentor and train new manufacturing personnel on all safety, quality, and production systems.
• Independently use, calibrate, and maintain all instrumentation required for radiopharmaceutical manufacturing operations.
• Plan and organize production Work Orders in collaboration with leadership.
• Author, review, and revise cGMP documentations while upholding NorthStar’s QMS guidelines.
• Perform safety checks and routine inspection of the processing equipment and control systems.
• Maintain accurate inventory of materials and consumables.
• Perform and assist in maintaining the cleanliness and orderliness of the facility.
• Engage in completion of all workflows inside QMS including deviations, OOSs, change controls, document changes (DCO), and CAPA.
• Contribute to interdepartmental projects including production scale-up and continuous process improvement.
• Monitor product quality to ensure compliance with standards and specifications.

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories.
• Be trained on essential analytical equipment and procedures pertaining to radiolabeling and QC.
• Complete Operator training for drug products in and near production readiness.

After 6 months you will:

• Be trained on all procedures pertaining to radiolabeling and QC.
• Have a minimum of 50 hours of experience handling Ac225.
• Have a complete understanding of BE5 workflow and operations.

Qualifications

Pharm D or similar training and minimum two (2) years of experience in practicing nuclear pharmacy procedures. Board Certified Nuclear Pharmacist (BCNP) credential is preferred. Previous experience in a good manufacturing practices (cGMP) setting is preferred. Must maintain an active pharmacist license. Authorized User of radioactive materials certification is required.

Working Conditions

Physical demands may include specific vision abilities including near vision/acuity and visual color discrimination. The work environment may include exposure to a heated/air-conditioned indoor office/manufacturing/cleanroom setting. Employees must be willing and able to wear various types of PPE, including respirators, gloves, and safety glasses, as required by the job.

Location

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis., which is our primary manufacturing site. Beloit offers a blend of urban opportunities and rural beauty.

NorthStar Medical Radioisotopes is an equal opportunity employer.