PET Center Regulatory & Safety Leader (Associate Director)

RightReadMD; New York (NY); Sur place; USD 190 000 - 215 000; Plein temps

Résumé du poste

Columbia University Irving Medical Center’s Radiology, Division of Molecular Imaging and Therapeutics Research is seeking an Associate Director, Regulatory & Safety, PET Center. The pharmacist will lead regulatory and quality programs for radiopharmaceutical production and PET imaging operations.

The role requires PharmD (or equivalent), NY license, and substantial experience in radiopharmacy, regulatory affairs, and FDA inspections.

Qualifications

• Doctor of Pharmacy (PharmD) or equivalent professional pharmacy degree.
• Current New York State pharmacist license or eligibility.
• Experience in hospital/nuclear pharmacy, radiopharmacy, or related environment.

Responsabilités

• Provide pharmacy leadership and operational oversight for clinical PET radiopharmaceutical procurement, preparation, dispensing, and administration.
• Collaborate with radiochemists and clinical staff to ensure availability and safe use of radiopharmaceuticals for imaging and research.
• Develop and implement SOPs and quality processes for clinical radiopharmaceutical operations.
• Serve as a regulatory and quality resource for FDA inspections, licenses, and regulatory documentation.
• Support investigation and translation of radiopharmaceutical production methods into compliant manufacturing processes.
• Maintain readiness for regulatory inspections and ensure documentation meets regulatory standards.

Connaissances

Regulatory compliance

Quality systems

FDA inspections

Pharmacy leadership

Formation

PharmD or equivalent

Outils

GE FX

FASTlab

Automated radiochemistry systems

Description du poste

Columbia University Irving Medical Center’s Radiology, Division of Molecular Imaging and Therapeutics Research is seeking an Associate Director, Regulatory & Safety, PET Center. The pharmacist will lead regulatory and quality programs for radiopharmaceutical production and PET imaging operations.

The role requires PharmD (or equivalent), NY license, and substantial experience in radiopharmacy, regulatory affairs, and FDA inspections.