Scientist

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.
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Key Responsibilities:<\/b>
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• Support radiopharmaceutical drug product development activities from early -stage through late -stage programs
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• Design, execute, and analyze laboratory experiments supporting process development and optimization
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• Support CMC activities related to drug product development, process characterization, and manufacturing readiness
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• Participate in technology transfer activities between development and manufacturing teams
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• Support preclinical, clinical, and/or commercial -stage development activities
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• Collaborate with cross -functional groups including Manufacturing, Quality, Regulatory, Analytical Development, and Technical Operations
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• Document experimental work and maintain compliant records following cGMP and GDP requirements
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• Assist with troubleshooting technical challenges and identifying process improvements
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• Support regulatory submission activities and/or commercialization efforts where applicable
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  Required Qualifications:<\/b>
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  • Bachelor's, Master's, or PhD in Chemistry, Radiochemistry, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline
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  • Experience ranging from Scientist to Senior Scientist level within radiopharmaceuticals, pharmaceuticals, biotechnology, or related industry
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  • Experience supporting radiopharmaceutical or drug product development activities
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  • Knowledge of CMC principles and regulated development environments
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  • Understanding of cGMP documentation practices
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  • Strong scientific problem -solving and communication skills
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    Preferred Qualifications:<\/b>
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    • Experience with radiopharmaceutical drug product development
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    • Experience supporting technology transfers
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    • Exposure to pre -clinical and/or late -stage development programs
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    • Experience supporting commercialization activities or NDA -related programs
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    • Experience with radioisotopes such as Ac -225, Lu -177, In -111, or similar therapeutic/diagnostic isotopes
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    • Familiarity with analytical techniques such as HPLC, TLC, GC, or related methods
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    • Validation experience is considered a plus but is not required
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      Additional Skills:<\/b>
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      • Ability to work independently and within cross -functional teams
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      • Strong organizational and project management skills
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      • Ability to manage multiple priorities in a fast -paced environment
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