Intern - Radiopharmaceutical Manufacturing

5 days ago

Brownsburg America Caribbean Canada USA Indiana Orano Full time US$80,000 - US$120,000 per year


General information

Organization

Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.

Find out more about Orano Med  

Location

PLANO - Texas

Job description (internal)

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.


Skills and Qualifications (internal)

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

Employment Classification

Student


Job

N - Laboratory

Customizable block no. 2
Overtime status

Non-exempt


Relocation

No


Job location

America / Caribbean / Canada, USA, Indiana


Geolocation by area (Always put 'Yes')

No


Adress


Brownsburg

Additional information
Telework/Home-office

In Office

Applicant criteria
Travel

No

Handled by
Primary manager

Emily HUGHEY

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