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Chemist II - Noblesville, Indiana

Date:  Mar 3, 2021
Location: 

Noblesville, IN, United States

About Curium

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

This position is located in our Noblesville, Indiana location and in the role of Chemist II you will serve as part of the production team responsible for the processing of bulk radiopharmaceuticals in a highly regulated (FDA/NRC) environment.  This position will be responsible for the manufacturing of radiopharmaceuticals, preparation of production materials, general production equipment maintenance, and quality control (QC) of products.

Essential Functions

  • 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 radio¬pharmaceutical products and substances
  • Optimize and validate QC methods and procedures necessary for validating radiopharmaceutical products.
  • Carry out production responsibilities to meet the manufacturing schedule.
  • Assist in the general lab cleaning, stocking of supplies, and maintenance activities.
  • Ensures regulatory compliance of production and QC protocols during manufacturing operations.
  • Assists with creating and optimizing SOPs for use in Production and QC.
  • Compile, prepare, and submit development reports
  • May assist with the preparation of regulatory submissions including compiling CMC sections of related applications.
  • Support and execute Continuous Process Improvement (CPI) initiatives through implement¬ation of Deviation Reporting, OOS and Root Cause Investigations, CAPA, and Change Control.
  • Performs other duties as assigned.

Requirements

  • Bachelor's Degree in Chemistry, Biochemistry, Chemical Engineering or a related field. In lieu of, an Associates' Degree in Chemistry or Chemical Engineering along with a minimum of 3 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/qualification protocols.
  • Proven experience working within and across teams building a collaborative culture
  • Excellent communication, organization, analytical and computer skills (including proficiency in Microsoft Office).
  • Experience working in a team environment.
  • Proven abilities to handle responsibilities in a demanding manufacturing environment with minimal oversight.
  • While performing the duties of this position, the employee must be able to work under stress, deadlines and able to adapt to changing conditions.

 

Working Conditions

  • Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Standard office environment, coupled with working in radiopharmaceutical manufacturing and laboratory environments.
  • Occupational exposure to radiation.
  • 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.  
  • Responsibilities also include light to moderate physical exertion, including occasional standing, bending, reaching and occasional lifting and carrying of light to moderate loads (of up to 55 pounds) as well as the ability to walk, stoop, push, pull, and climb stairs without accommodation.  
  • Must possess good hand-eye coordination.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 


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