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Manufacturing Chemist

Company: CURIUM
Location: Noblesville
Posted on: May 28, 2023

Job Description:

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position The Manufacturing Chemist position will serve as part of the production team responsible for the processing of bulk radiopharmaceuticals including production preparation and equipment maintenance activities in a highly regulated (FDA/NRC) environment. This position is in our Noblesville, Indiana location. Work Schedule: Monday - Friday 8:00am - 4:30pm. Ability to work overtime as needed. Essential Functions

  • Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP's and cGMP.
  • Manufacture radiopharmaceutical products, prepare production materials and supplies, perform general production equipment maintenance, and test finished products.
  • Perform analytical methods and procedures for QC testing of GMP manufactured radiopharmaceutical products and substances.
  • Optimize and validate QC methods and procedures necessary for validating radiopharmaceutical products.
  • Carry out production responsibilities including cross-functional coordination to meet the manufacturing schedule.
  • Assist in the general lab cleaning, stocking of supplies, and maintenance activities.
  • Ensure regulatory compliance of production and QC products during manufacturing operations.
  • Assists with creating and optimizing SOP's for use in Production and QC.
  • Create and execute protocols as needed.
  • Provide training as needed to Production Chemists.
  • Troubleshoot problems including those of a complex nature.
  • Develop and promote equipment and process improvements which serve to improve reliability, increase output, and reduce radiation exposure.
  • Assist in driving cost savings initiatives for the department. Ensure department safety, quality, and financial metrics are achieved.
  • Must actively manage personal radiation exposure as well as exposures of shift personnel per prescribed policies, procedures, and guidelines.
  • Compile, prepare, and submit development reports.
  • May assist with preparation of regulatory submissions including compiling CMC sections of related applications.
  • Support and execute Continuous Process Improvement (CPI) initiatives through implementation of Deviation Reporting, OOS and Root Cause Investigations, CAPA, and Change Control.
  • Perform other duties as assigned. Requirements
    • Bachelor Degree in Chemistry, Biochemistry, Chemical Engineering, or a related field preferred. Associate Degree in Chemistry with a minimum of three years of related experience working in a pharmaceutical manufacturing environment with preference in radiopharmaceuticals may be considered.
    • Experience with ICP-MS, ICP-OES, HPLC, Gas Chromatography (GC) and other chemistry related equipment.
    • Prior experience working in a GMP environment, preferably within the radiopharmaceutical industry.
    • Familiarity with cyclotron solid targets along with the dissolution and separation of radioisotopes preferred.
    • Familiarity with radiation protection and safe handling of radioactive materials preferred.
    • Demonstrated technical writing skills with experience describing chemical and mechanical processes in support of production and QC procedures along with validation/qualifications protocols.
    • Excellent communication, organization, analytical and computer skills (including proficiency in Microsoft Office).
    • Proven abilities to handle responsibilities in a demanding manufacturing environment with minimal oversight. While performing duties of this position, the employee must be able to work under stress, deadlines and able to adapt to changing conditions.
    • Experience with Chemistry related equipment.
    • Good team building and collaborative mindset. 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.
      • Must be willing to wear a variety of personal protective equipment.
      • Willingness to work in a team-based environment.
      • Close attention to detail required.
      • May be required to sit or stand for long periods of time while performing duties.
      • Must be able to work outside of regular work hours, nights, overtime, weekends, and holidays.
      • Frequent handling of radioactive cyclotron components.
      • Responsibilities also include the ability to lift up to 50 lbs, walk, bend, stoop, push, pull, reach, and climb ladders and stairs with or without accommodation.
      • Must possess good hand-eye coordination.

Keywords: CURIUM, Noblesville , Manufacturing Chemist, Other , Noblesville, Indiana

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