Job Description

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.

Quality Control Responsibilities:

• 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.)

Work Environment:
Location: RadioMedix Spica Center, 19705 Aldine Westfield Rd, Humble, TX

Work Conditions:
The work environment consists of manufacturing, laboratory and office spaces. The position will sometimes require more than forty hours of work per week. The work period is typically between 8:30 AM to 5 PM.

Individuals in this position will be exposed to ionizing radiation; however, radiation safety training will be provided and radiation monitoring is required and ongoing at the facilities. Any exposure will be within Federal and State limits. Individuals in this position are required to be able to function and maneuver within the work environment without placing self, the product or others at risk.

The position requires physical strength and dexterity with the ability to climb on ladders and up on equipment for environmental service and maintenance responsibilities.