Scientist

Genovice • Indianapolis, IN

1d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level