Senior Radiopharmaceutical Manufacturing Specialist

Responsibilities

• Operate as Subject Matter Expert (SME) across various aspects of radiopharmaceutical manufacturing including but not limited to the manufacturing of the intermediate and finished dose production processes. This includes 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 the accurate and timely preparation and completion of records related to manufacturing, including Batch Records, Forms, Log Books, etc.
• Participate in internal and external compliance audits and assist with auditor interactions as needed.
• 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 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 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 facility, equipment, and materials in accordance with NorthStar’s respective policies and procedures.
• Engage in completion of all workflows inside QMS including deviations, OOSs, change controls, document changes (DCO), and CAPA.
• Work cross-functionally on employing standardized root cause analysis, investigation tools and methodologies.
• Contribute to interdepartmental projects including production scale-up, product development, continuous process improvement which includes qualification and validation activities.
• Work with Facilities and Maintenance group on preventative maintenance (PM) review and troubleshooting implementation plan, and assist in tracking scheduled system maintenance and equipment calibrations while keeping an open line of communication.
• Monitor product quality to ensure compliance with standards and specifications by identifying and verifying appropriate materials, area conditions, and process for production. Communicate any abnormalities to the leader.

Early Development

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 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

1st shift (CDMO): This position supports development and manufacturing of radiopharmaceuticals used in time-sensitive patient treatments. The primary schedule is Monday through Friday. Flexibility to work alternate shifts, overtime, and holidays is occasionally required to ensure on-time delivery of critical doses for scheduled patient care.

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, both indoors (heated/air-conditioned spaces) and outdoors. Noise levels range from quiet to loud, depending on the work area. Specific vision abilities, including near vision, visual acuity, and color discrimination. Personal Protective Equipment (PPE) is required and may include: Respirators, gloves, safety glasses, and full protective clothing. Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings). Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions. As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to: 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.