Quality Control Manager

University of California - San Francisco; San Francisco (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

The University of California - San Francisco is seeking a Quality Control Manager who will apply extensive knowledge of clinical radiopharmaceuticals. This role involves ensuring the quality of investigational radiopharmaceuticals and developing quality control standard operating procedures.

The ideal candidate will have at least a Bachelor's degree in chemistry or a related subject and over 5 years of experience in a GMP radiopharmaceutical facility. Candidates with a Master's degree and knowledge of regulatory requirements will be preferred.

Qualifications

• Minimum of 5 years of related experience in a GMP radiopharmaceutical facility.
• 3 years' experience in quality control of cGMP PET Radiopharmaceuticals.
• Ability to adapt quickly to changing priorities in a fast-paced environment.

Responsibilities

• Ensure quality of investigational radiopharmaceuticals per regulatory requirements.
• Assist in creating quality control standard operating procedures.
• Work on investigational drug applications and develop new quality control approaches.

Skills

Project leadership

Critical thinking

Problem-solving

Interpersonal skills

Teamwork development

Education

Bachelor's degree in chemistry or related area

Master's degree in chemistry or related area

Job description

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