Senior Radiopharmaceutical Manufacturing Specialist (3rd shift)

Responsibilities

• Operate as Subject Matter Expert (SME) across radiopharmaceutical manufacturing including intermediate and finished dose production processes, pre-production set-up, manufacturing processes, post-production activities, and waste stream management.
• Mentor and train new manufacturing personnel on all safety, quality, and production systems.
• Assist in accurate and timely preparation and completion of manufacturing records including Batch Records, Forms, and Log Books.
• Participate in internal and external compliance audits and assist with auditor interactions.
• Support the business development team in interaction with current and potential sponsors.
• Plan and organize production Work Orders on the production schedule in collaboration with leadership.
• Author, review, and revise cGMP documentation such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Work Instructions (WI), and Production Checklists while upholding QMS guidelines.
• Perform safety checks and routine inspection of processing equipment, control systems, consumables, and cleanrooms.
• 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.
• Maintain cleanliness and orderliness of the facility, equipment, and materials.
• Engage in completion of all workflows inside QMS including deviations, OOSs, change controls, document changes (DCO), and CAPA.
• Work cross-functionally on standardized root cause analysis, investigation tools, and methodologies.
• Contribute to interdepartmental projects including production scale-up, product development, and continuous process improvement including qualification and validation activities.
• Work with Facilities and Maintenance on preventative maintenance (PM) review, troubleshooting implementation plans, and tracking scheduled system maintenance and equipment calibrations.
• Monitor product quality to ensure compliance with standards and specifications and communicate abnormalities to the leader.

Early Development

After 3 months: 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 with cross-functional teams including Quality, Science, and Engineering; gain hands-on experience with state-of-the-art manufacturing technology.

After 6 months: achieve Qualified Operator status with demonstrated competency to execute full batch manufacturing of novel isotopes; contribute to Operational Excellence by maintaining KPIs and metrics; fully integrate into NorthStar's mission; develop advanced technical skills in handling sophisticated manufacturing processes and technologies.

Qualifications

• Associate's Degree (AS) in a STEM discipline and minimum four (4) years of cGMP (pharmaceutical) experience; or equivalent combination of education and experience.
• Relevant military experience will also be considered.
• Bachelor's Degree (BS) in a STEM discipline and minimum four (4) years of cGMP (pharmaceutical) experience preferred.
• CDMO/CMO experience, chemistry experience, and knowledge of aseptic processes (cleanroom environment) and equipment qualification preferred.

Shift Information

Third shift hours are Monday - Thursday 9pm - 7:30am (shift ends Friday morning). During the approximately 60-day training period, the ability to work alternate shifts is required. This position supports production in a 24-hour manufacturing facility; occasional overtime, weekends, and holidays are required. Eligible for an additional $5.00/hour shift premium for hours worked between 6:00pm and 6:00am.

Working Conditions

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include exposure to varying temperatures, noise levels ranging from quiet to loud, and requirements for specific vision abilities including near vision, visual acuity, and color discrimination. PPE is required and may include respirators, gloves, safety glasses, and full protective clothing. Cleanroom gowning protocols apply, including removal of all jewelry and prohibition of cosmetics, fragrances, and nail products. As a radiopharmaceutical manufacturing site, radiation may be present; employees may be required to follow strict radiation safety procedures, participate in dosimetry monitoring and bioassay testing, and inform leadership of any health conditions that may affect product integrity.