Radiopharmaceutical Manufacturing Specialist (2nd shift)

NorthStar Medical Radioisotopes • Beloit, WI

11d • Onsite

About The Position

The Radiopharmaceutical Manufacturing Specialist supports the manufacture of radiopharmaceuticals for NorthStar operations. Duties include equipment preparation, product dissolution, and dispensing medical radioisotopes while following procedures, instructions, prescribed routines, and applicable regulatory standards. The role suits someone comfortable with repetitive processes, structured schedules, and production work.

The position contributes to pre-production setup, manufacturing, post-production activities, waste stream management, production documentation, equipment and cleanroom checks, inventory control, and process improvement. The employee works with cross-functional teams and is trained toward qualified operator status for full-batch manufacturing.

The regular second-shift schedule is Monday through Thursday, 1:00 p.m. to 11:30 p.m. During approximately 60 days of training, the ability to work alternate shifts is required. The role supports a 24-hour manufacturing facility and requires occasional overtime, weekend, and holiday work. A $5.00-per-hour shift premium applies to hours worked between 6:00 p.m. and 6:00 a.m.

Work may take place in a controlled cleanroom, office, or manufacturing area. Employees may encounter varying temperatures and noise levels, must follow cleanroom gowning rules, and may be exposed to radiation in laboratory and production areas. Required safety measures can include PPE, radiation safety procedures, dosimetry monitoring, and bioassay testing. The position is based at NorthStar Medical Radioisotopes’ Beloit, Wisconsin facility and is eligible for a lump-sum relocation benefit.

Requirements

• Associate’s degree in a STEM discipline and at least two years of experience in cGMP pharmaceutical or medical-device work, ISO 15189 hospital work, CLIA clinical laboratory work, ISO 9001 industrial manufacturing, IATF 16949 automotive work, or AS9100 aerospace work; an equivalent combination of education and experience is also accepted.
• Relevant military experience will be considered.
• Ability to work second shift, Monday through Thursday, 1:00 p.m. to 11:30 p.m., and alternate shifts during the approximately 60-day training period.
• Ability to work occasional overtime, weekends, and holidays.
• Ability to comply with cleanroom gowning protocols, including restrictions on jewelry, cosmetics, fragrances, and nail products.
• Ability to follow radiation safety procedures and participate in dosimetry monitoring and bioassay testing as required.
• Must be able to demonstrate identity and employment authorization through Form I-9 on or before the first day of employment; the company does not provide immigration-related sponsorship.

Nice To Haves

• Bachelor’s degree in a STEM discipline and at least two years of qualifying regulated-industry experience.
• CDMO/CMO experience.
• Chemistry experience.
• Knowledge of aseptic processes, cleanroom environments, and equipment qualification.

Responsibilities

• Perform radiopharmaceutical manufacturing activities, including pre-production setup, manufacturing processes, post-production activities, and waste stream management.
• Assist with accurate and timely preparation and completion of manufacturing records, including batch records, forms, and logbooks.
• Review production work orders on the production schedule.
• Author, review, and revise cGMP documentation, including Batch Production Records, Standard Operating Procedures, work instructions, and production checklists, in accordance with NorthStar’s QMS guidelines.
• Perform safety checks and routine inspections of production equipment and control systems, consumables, and cleanrooms; notify the leader of equipment or operating problems and needs for materials, supplies, or investigations.
• Maintain accurate inventories of materials and consumables and coordinate equipment traceability under the direction of the leader.
• Help maintain cleanliness and order in cleanrooms, manufacturing spaces, equipment, and materials in accordance with company policies and procedures.
• Work cross-functionally using standardized root-cause analysis, investigation tools, and methodologies.
• Contribute to interdepartmental projects, including production scale-up and continuous process improvement.
• Follow radiation safety procedures and participate in dosimetry monitoring and bioassay testing as required by company protocol.

Benefits

• Medical, dental, and vision insurance
• Healthcare Flexible Spending Account and Dependent Care Flexible Spending Account
• Company-paid short-term and long-term disability
• Company-paid life insurance and AD&D coverage
• Pet insurance
• 401(k) match
• Paid holidays and paid time off
• Paid parental leave
• Bonus plan
• Equity Incentive Program
• Additional $5.00-per-hour shift premium for hours worked between 6:00 p.m. and 6:00 a.m.
• Lump-sum relocation benefit

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree