Quality Control Manager
The Quality Control Manager applies extensive knowledge of clinical radiopharmaceuticals to ensure the quality of investigational radiopharmaceuticals specified by the standards stated in the USP Chapter <823> and the laboratory requirements of 21 CFR 212. This position will report to the Director of the Radiopharmaceutical Facility in the development of quality control standard operating procedures for the investigational PET drugs such that the facilities, equipment, and inventory control meet the associated regulatory requirements. This position will also assist in creating new approaches in the quality control of novel radiopharmaceuticals for clinical use, and in working with the director in writing investigational drug applications (IND) and Abbreviated New Drug Applications (ANDA). The background for this position requires a minimum of a BS in chemistry or related subject with at least 5 years experience in a GMP radiopharmaceutical facility.
Required Qualifications
- Bachelor's degree in chemistry or related area
- Minimum of 5+ years of related experience
- 3 years’ experience in quality control of cGMP PET Radiopharmaceuticals
- Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities
- In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems
- Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals
Preferred Qualifications
- Master’s degree in chemistry or related area
- Knowledge of 21CFR212 and USP 823 regulatory requirements