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