Radiopharmaceutical Manufacturing Associate/Specialist (2nd or 3rd shift)

Overview

Accelerate your career with NorthStar!

Do you have an Associate’s or Bachelor’s degree in a STEM discipline and want to be part of a game-changing organization that has the potential to help cure cancer?

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 along with customized radiopharmaceutical development services.

We are seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Pro-Active and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner.  If selected to join our rapidly growing Radioisotope Manufacturing team, you will have the opportunity to gain hands-on experience, grow professionally and build a comprehensive understanding of our processes, positioning yourself for the opportunity to perform more complex work with increasing responsibility within NorthStar. 

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 Associate/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).  

Physical demands may include, but not be limited to, 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 with adequate ventilation and lighting and outdoor environments with varying temperatures.  The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions.  Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols.  This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment.  In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders. 

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

Responsibilities

• Execute various aspects of radiopharmaceutical manufacturing, including pre-production set-up, manufacturing processes, and post-production activities.
• Assist in the accurate and timely preparation and completion of records related to manufacturing, including Batch Records, Forms, Log Books, etc.
• Perform safety checks and routine inspection of the processing equipment, consumables, and cleanrooms to ensure effective production. Notify leader of equipment or operating problems and the need for additional materials, supplies, or investigations.
• Receive and track inventory of materials, consumables, and equipment list and report any deficiencies to 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.
• Support troubleshooting of manufacturing equipment and process issues, and escalating manufacturing, safety, and compliance issues.
• Support interdepartmental activities including production scale-up and continuous process improvement.

The Specialist will have additional responsibilities, including:

• Execute waste stream management.
• 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 on control systems.
• Maintain accurate inventory of materials and consumables, and coordinate equipment traceability under the direction of the leader.
• 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.

Qualifications

Radiopharmaceutical Manufacturing Associate

Associate’s Degree (AS) in a STEM discipline; or equivalent combination of education and experience.  Relevant military experience will also be considered. Bachelor’s Degree in a STEM discipline and minimum one year (1) of cGMP experience preferred. 

Radiopharmaceutical Manufacturing Specialist

Associate’s Degree (AS) in a STEM discipline and minimum two (2) years of cGMP experience; or equivalent combination of education and experience.  Relevant military experience will also be considered.  Bachelor’s Degree in a STEM discipline and minimum two years (2) of cGMP experience preferred.  Working knowledge of ERP systems is desired.

Location

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.

NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law.

Salary : $25