Radiopharmaceutical Manufacturing Specialist (2nd Shift)

NorthStar Medical Radioisotopes•Beloit, WI

2d•Onsite

About The Position

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, NorthStar Medical Radioisotopes is the place to do it. 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. At the forefront of NorthStar’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.

Requirements

Associate’s Degree (AS) in a STEM discipline and minimum two (2) years of cGMP (pharmaceutical or medical device), ISO 15189 (hospital), CLIA (clinical laboratory), ISO 9001 (industrial manufacturing), IATF 16949 (automotive) or AS9100 (aerospace) experience; or equivalent combination of education and experience.
Relevant military experience will also be considered.
Candidates must be able to work alternate shifts during the training period (approximately 60 days).
Follow strict radiation safety procedures.
Participate in dosimetry monitoring and bioassay testing as part of the company protocol.
Inform leadership of any health conditions that may affect product integrity, by cleanroom standards.

Nice To Haves

Bachelor’s Degree (BS) in a STEM discipline and minimum two (2) years of cGMP (pharmaceutical or medical device), ISO 15189 (hospital), CLIA (clinical laboratory), ISO 9001 (industrial manufacturing), IATF 16949 (automotive) or AS9100 (aerospace) experience preferred.
CDMO/CMO experience, chemistry experience and knowledge of aseptic processes (cleanroom environment) and equipment qualification preferred.

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.