Senior Radiopharmaceutical Manufacturing Lead

NorthStar Medical Technologies; Beloit (WI); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

NorthStar Medical Radioisotopes in Beloit, WI seeks an experienced Subject Matter Expert for radiopharmaceutical manufacturing. You will oversee intermediate and finished-dose production, ensure cGMP compliance, and manage records and deviation investigations alongside cross-functional teams.

You will mentor staff, support audits, and contribute to process improvements, scale-up projects, and QA activities within a fast-growing facility.

Competenze

• Associate’s Degree (AS) in a STEM discipline and minimum four (4) years of cGMP (pharmaceutical) experience; or equivalent combination of education and experience.
• Bachelor’s Degree (BS) in a STEM discipline and minimum four (4) years of cGMP (pharmaceutical) experience preferred; CDMO/CMO experience and aseptic processes knowledge preferred.

Mansioni

• Serve as SME across radiopharmaceutical manufacturing including intermediate and finished dose production; pre-production setup, manufacturing, post-production activities and waste stream management.
• Mentor and train manufacturing personnel on safety, quality, and production systems.
• Prepare and complete records such as Batch Records, Forms, and Log Books accurately and timely.
• Support internal/external audits and assist with auditor interactions as needed.
• Assist business development in interactions with sponsors and manage production schedules with leadership.

Conoscenze

cGMP

Radiopharmaceutical manufacturing

Documentation

QA & Audits

Mentoring/Training

Production planning

Equipment qualification

Formazione

AS in STEM

BS in STEM

Descrizione del lavoro

NorthStar Medical Radioisotopes in Beloit, WI seeks an experienced Subject Matter Expert for radiopharmaceutical manufacturing. You will oversee intermediate and finished-dose production, ensure cGMP compliance, and manage records and deviation investigations alongside cross-functional teams.

You will mentor staff, support audits, and contribute to process improvements, scale-up projects, and QA activities within a fast-growing facility.