MISSION:

Ensures quality control efforts are performed in accordance with established chemistry, manufacturing, and controls specifications for Ga68 generators and upcoming projects in the pipeline.

• Must have at least 2-3 years of QC experience in biotech, pharma, or cGMP
• Conducts analytical/quality control testing in accordance with cGMP (21 CFR 211) for API and Drug products to ensure safety for the patient/end user
• Follows pertinent RadioMedix Quality Control procedures for e.g. Identity testing, radiochemical purity, radionuclidic purity, endotoxin and sterility
• Preforms analytical testing with proficiency in equipment e.g. HPLC, TLC, ICPMS, HPGE/Gamma Spec
• Completes and maintains appropriate documentation required by federal and state agencies
• Sets up and maintains automated chemistry modules and laboratory equipment
• Supports RadioMedix’s development of radiochemical processes
• Ensures Quality Control methods are in conformity with cGMP
• Assist in the development of procedures, test reports, operating procedures, and maintenance procedures for new or updated processing equipment.
• Drafts pertinent protocols, reports and documentation to support API and Drug Product
• Tests materials upon incoming receipt if required according to RadioMedix release specifications
• Ensures chemicals on site are properly managed in appropriate conditions with appropriate documentation e.g. Safety Data Sheets
• Trains new QC employees
• Coordinates third party testing of raw materials if required

Analytical Method Development Responsibilities:

• Development of procedures in the quality control of radiopharmaceuticals/API using a variety of instruments such as HPLC, GC, TLC, and ICP-MS.
• Develop and improve analytical methods used in assessing the radiochemical attributes of the company products
• Write necessary SOPs, Validation Protocols and Validation Report

Radiation Safety responsibilities:

• Supports wipes and surveys of the facility to ensure state of control
• Provides basic support and supervision for ensuring calibration of all radiation instrumentation
• Performs radiation safety duties to assure compliance with all regulations.
• Assesses the nuclear waste characteristics of the group’s chemical processes to support regulatory and waste classification exercises.

Other Responsibilities:

• Be self-motivated and able to work as a team member when needed
• Ensures a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s.
• Follows and promote on-the-job safety expectations, including wearing proper Personal Protective Equipment (PPE) and following cGMP rules and guidelines in all designated areas.
• Ability to meet the physical demands of the job (standing for long periods of time, lifting heavy loads of up to 40 pounds etc.)