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Senior Manufacturing Chemist

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Beacon Hill

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Location:
United States , Indianapolis

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

50000.00 - 60000.00 USD / Year
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Job Description:

The Senior Manufacturing Chemist 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.

Job Responsibility:

  • Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP’s and cGMP
  • 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.)
  • Manufacture radiopharmaceutical products, prepare production materials and supplies, perform general production equipment maintenance, and production inventory management
  • Carry out production responsibilities including cross-functional coordination to meet the manufacturing schedule
  • Assist in the general lab cleaning and stocking of supplies
  • Ensure regulatory compliance
  • Create and optimize SOPs as needed
  • Create and execute protocols as needed
  • Support and execute Continuous Process Improvement (CPI) initiatives through implementation of CAPA, protocols and Change Control
  • Author Quality Events as needed (deviations, OOS, CAPA, CC)
  • 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
  • Must maintain Class 1 Radiation Worker training qualifications
  • Collateral duties, special projects and other duties assigned by Management

Requirements:

  • Bachelor degree in Chemistry, Biochemistry, Chemical Engineering, or a related field
  • 3 or more years of relevant experience required
  • Proven abilities to handle responsibilities in a demanding manufacturing environment with minimal oversight
  • Experience with Chemistry related equipment
  • Experience working in a GMP environment
  • 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
  • Skills/Competencies: Action Oriented, Problem Solving, Decision Quality, Directing Others, Technical Writing Skills, Written Communications, Creativity and Organization
  • Good team building and collaborative mindset

Nice to have:

  • Familiarity with cyclotron solid targets along with the dissolution and separation of radioisotopes
  • Familiarity with radiation protection and safe handling of radioactive materials

Additional Information:

Job Posted:
March 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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