Radiopharmaceutical Manufacturing Specialist (3rd shift)

About the role

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. 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.

Responsibilities

• Execute various aspects of radiopharmaceutical manufacturing, including pre-production set-up, manufacturing processes, post-production activities, and waste stream management.
• Absolutely 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.

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.
• CDMO/CMO experience, chemistry experience and knowledge of aseptic processes (cleanroom environment) and equipment qualification preferred.

Qualifications

• 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.
• 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.

Skills

• Strong attention to detail and organizational skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.
• Knowledge of GMP regulations and standards.
• Experience with cGMP documentations and SOPs.
• Basic understanding of aseptic processes and cleanroom environments.

Benefits

• Exceptional career growth and professional development opportunities.
• World-class facilities and a competitive benefits package.

Pay

• Competitive compensation based on experience and qualifications.

Schedule

• Full-time position.