Quality Control Manager

About the role

The Quality Control Manager ensures the quality of investigational radiopharmaceuticals in accordance with USP Chapter and 21 CFR 212 standards. Reporting to the Director of the Radiopharmaceutical Facility, this role involves developing quality control SOPs, creating new approaches for quality control of novel radiopharmaceuticals, and assisting in IND and ANDA applications.

Responsibilities

• Ensures compliance with USP Chapter and 21 CFR 212 standards for investigational radiopharmaceuticals
• Develops quality control standard operating procedures for investigational PET drugs
• Maintains facilities, equipment, and inventory control to meet regulatory requirements
• Assists in creating new approaches for quality control of novel radiopharmaceuticals for clinical use
• Works with the Director in writing IND and ANDA applications

Requirements

• Minimum of a BS in chemistry or related field with 5+ years of related experience
• At least 3 years of experience in quality control of cGMP PET Radiopharmaceuticals
• Advanced ability to lead projects and adapt to a fast-paced environment
• In-depth critical thinking and problem-solving skills
• Excellent interpersonal skills, including leadership and teamwork

Qualifications

• Bachelor's degree in chemistry or related area
• Master’s degree in chemistry or related area preferred
• Knowledge of 21CFR212 and USP 823 regulatory requirements