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Scientist

icon building Company : Genovice
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Job Description - Scientist

Job Title: Scientist / Senior Scientist – Radiopharmaceutical Drug Product Development (CMC)
Location: Indianapolis, IN

Overview:
Our client is seeking a Scientist/Senior Scientist to support radiopharmaceutical drug product development activities across pre -clinical through late -stage programs. This individual will support CMC -driven initiatives including process development, technology transfer, scale -up activities, and commercialization efforts within a regulated environment. The ideal candidate will bring a strong radiopharmaceutical background with experience supporting drug product development programs and cross -functional collaboration.

Key Responsibilities:

  • Support radiopharmaceutical drug product development activities from early -stage through late -stage programs

  • Design, execute, and analyze laboratory experiments supporting process development and optimization

  • Support CMC activities related to drug product development, process characterization, and manufacturing readiness

  • Participate in technology transfer activities between development and manufacturing teams

  • Support preclinical, clinical, and/or commercial -stage development activities

  • Collaborate with cross -functional groups including Manufacturing, Quality, Regulatory, Analytical Development, and Technical Operations

  • Document experimental work and maintain compliant records following cGMP and GDP requirements

  • Assist with troubleshooting technical challenges and identifying process improvements

  • Support regulatory submission activities and/or commercialization efforts where applicable

Required Qualifications:

  • Bachelor's, Master's, or PhD in Chemistry, Radiochemistry, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline

  • Experience ranging from Scientist to Senior Scientist level within radiopharmaceuticals, pharmaceuticals, biotechnology, or related industry

  • Experience supporting radiopharmaceutical or drug product development activities

  • Knowledge of CMC principles and regulated development environments

  • Understanding of cGMP documentation practices

  • Strong scientific problem -solving and communication skills

Preferred Qualifications:

  • Experience with radiopharmaceutical drug product development

  • Experience supporting technology transfers

  • Exposure to pre -clinical and/or late -stage development programs

  • Experience supporting commercialization activities or NDA -related programs

  • Experience with radioisotopes such as Ac -225, Lu -177, In -111, or similar therapeutic/diagnostic isotopes

  • Familiarity with analytical techniques such as HPLC, TLC, GC, or related methods

  • Validation experience is considered a plus but is not required

Additional Skills:

  • Ability to work independently and within cross -functional teams

  • Strong organizational and project management skills

  • Ability to manage multiple priorities in a fast -paced environment




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About the Company

Genovice

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