Radiopharmaceutical Manufacturing Specialist

Overview

Accelerate your career with NorthStar!

 

NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner.  We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.

 

At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities. 

 

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, paid parental leave and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

Position

The Radiopharmaceutical Manufacturing Specialist performs duties to support the development and manufacturing of radiopharmaceuticals for NorthStar operations.  This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities 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. Requirements for this position include the ability to work 1st, 2nd, and 3rd shifts during the training period (several months).  

Responsibilities

• Execute various aspects of radiopharmaceutical manufacturing, including pre-production set-up, manufacturing processes, post-production activities, and waste stream management.
• Assist in the accurate and timely preparation and completion of records manufacturing, including Batch Records, Forms, Logbooks, etc.
• Review production Work Orders on the production schedule.
• Author, review, and revise cGMP documentations, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Works Instructions (WI), and Production Checklists while upholding NorthStar’s QMS guidelines.
• Perform safety checks and routine inspection of the production processing equipment and control systems, consumables, and cleanrooms to ensure compliant manufacturing. Notify leader of equipment or operating problems and the need for additional materials, supplies, or investigations.
• Maintain accurate inventory of materials and consumables, and coordinate equipment traceability under the direction of the leader.
• Perform and assist in maintaining the cleanliness and orderliness of the cleanroom and/or manufacturing spaces, equipment, and materials in accordance with NorthStar’s respective policies and procedures.
• Work cross-functionally on employing standardized root cause analysis, investigation tools and methodologies.
• Contribute to interdepartmental projects including production scale-up and continuous process improvement.

After 3 months, you will:

Understand foundational cGMP and just-in-time radiopharmaceutical manufacturing principles

Become a qualified Radiation Worker, trained in ALARA principles and isotope-specific safety protocols.

Collaborate effectively with cross-functional teams, including Quality, Science, and Engineering, to ensure timely delivery of radiopharmaceuticals for cancer treatment.

Gain hands-on experience with state-of-the-art manufacturing technology under expert supervision.

After 6 months, you will:

Achieve Qualified Operator status with demonstrated competency to execute full batch manufacturing of novel isotopes.

Contribute to Operational Excellence by maintaining optimum KPIs and metrics to enhance production efficiency and quality.

Fully integrate into NorthStar’s mission to revolutionize oncology treatment by providing patients with global access to game-changing radiopharmaceuticals.

Develop advanced technical skills in handling sophisticated manufacturing processes and technologies, positioning yourself as a key player in an innovative and impactful field.

Qualifications

Associate’s Degree (AS) in a STEM discipline and minimum tw