Position Summary

The Intern – Radiopharmaceutical Manufacturing will participate in the establishment of ATLab Indianapolis as a new commercial-scale manufacturing facility for therapeutic radiopharmaceuticals. During Summer 2024, the facility will be concluding construction and qualification, so the Intern should focus efforts on: safety and occupational training, completing an assigned project, helping with basic tasks, growing in technical understanding, developing workplace skills, and building a professional network.

Safety and Compliance

• Read and follow all assigned relevant SOPs
• Safety: Reading/on-the-job training in radiation safety, hazardous materials, occupational safety.
• Assist with submissions and compliance for RAM license and environmental compliance.

Production, QC, Shipping

• Observe/assist with qualification of spaces: IQ/OQ/PQ of cleanrooms and aseptic spaces
• Assist with qualification (IQ/OQ/PQ) of new equipment and instrumentation.
• Observe and understand: function of all instrumentation; chemistry behind production of Pb-212 and radiolabeled final drug product; science behind all QC methods.
• Assist with implementation of new software: inventory management, chemical inventory, eBR, LIMS, dose ordering, shipping software, etc.
• Consumable supplies: assist with inventory management, including planning, purchasing, inspecting, and accepting incoming supplies.
• Assist with design and implementation of shipping equipment and procedures.

Quality Assurance

• Embody and promote a culture of quality and continuous improvement.
• Adhere to all applicable procedures, cGMP, company policies, and any other quality or regulatory requirements.
• Learn about and gain comfort with cGMP and QMS.
• Assist with preparing and reviewing documents: SOPs, vendor qualification forms, material acceptance forms, instrument qualification forms, etc.

Project

In consultation with the supervisor, the Intern is expected to identify and complete a project with reasonable scope during the period of the internship.

Travel

Amount: 1-3 optional travel opportunities

The intern may receive other tasks and responsibilities as assigned.

Education

• Field: pharmaceutical sciences, Pharm.D., engineering, chemistry, related fields
• GPA: 3.0+
• Status: Full-time student; Completed 2+ semesters

Experience

• Safety/Waste: occupational, laboratory, chemical, radiation
• GMP of pharmaceuticals
• Cleanrooms: gowning, cleaning, EM, aseptic technique

Professionalism

• Character: integrity; honesty; respects authority; follows rules/policies
• Customer service mindset
• Attendance: dependable, on time
• Detail-oriented: meticulous execution of tasks and documentation
• Concise, organized oral/written communication; excellent listening
• Represents employer well: follows policies and practices, professionalism, teamwork
• Adapts to various people/settings. People want to work with this individual.
• Successful working independently, in a team, or under a supervisor.
• Seizes opportunities to learn something new, accept a project, or help with a task.
• Overcomes difficult problems by pushing through challenges, seeking resources, and asking for help.
• Takes responsibility; does not make excuses.
• Problem-solving mindset: Identifies problems and takes initiative to solve them.
• Teachable; accepts feedback.

Physical

• Stand and sit for 6+ hours
• Lift/move up to 50 lbs.
• Wear cleanroom PPE