The Manufacturing Technician produces the Active Pharmaceutical Ingredient for cyclotron-based radiopharmaceuticals through purification of starting materials by means of chemical processing. This work is conducted in cGMP and NRC compliant laboratories utilizing advanced equipment in the creation of new products.

Work Schedule: Saturday - Tuesday 8:00pm - 6:30am. Ability to work overtime when necessary.

• Ensure a safe and quality working environment.
• Awareness of FDA, NRC, ALARA, and OSHA requirements.
• Work according to SOPs and cGMP guidelines.
• Train and qualify on the manufacturing processes of the area.
• Start up and shut down processing equipment.
• Ensure proper maintenance and cleanliness of equipment.
• Perform proper line clearances.
• Properly record data per SOPs and cGMP guidelines.
• Perform Batch Record calculations.
• Work within the team environment and interact with other departments for operational success.
• Accurately count materials and labels.
• Accurately label products.
• Ability to elevate abnormalities within a process to leadership.
• Use logical methods to solve problems with effective solutions and make quick quality decisions.
• Assist and support in investigations and process improvements.
• Participate in safety programs, committees, or teams.
• Prepare chemical solutions for processes by following standardized formulas.
• Follow both spoken and written directions.
• Communicate effectively, both written and verbally.
• Perform duties as assigned by leadership.
• Willingness to be flexible and adaptable to the needs of the department and business.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• High school diploma or GED equivalent is required. Associate degree is preferred.
• One or more years of relevant work experience in manufacturing required (regulated environment, attention to detail, and following detailed instructions).
• Knowledge of Good Manufacturing Practices c(GMP) and applicable Quality System Standards preferred.
• Willingness to work rotating shifts, weekends, and overtime, as necessary.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.