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