What are the responsibilities and job description for the Scientist / Senior Scientist, Radiopharmaceutical Development and Technology Transfer position at Hartmann Young?
Scientist / Senior Scientist, Radiopharmaceutical Development & Technology Transfer
Location: Salt Lake City, Utah
Travel: Approximately 10% (US travel)
Level: Scientist or Senior Scientist, depending on the experience and background of the successful candidate
About the Opportunity
Hartmann Young is partnered with a growing radiopharmaceutical biotechnology company seeking a Scientist or Senior Scientist, Radiopharmaceutical Development & Technology Transfer to join its team in Salt Lake City, Utah.
This role will focus on the development, optimisation, and transfer of radiopharmaceutical manufacturing processes to internal and external GMP manufacturing sites. The position offers significant cross-functional exposure across CMC, Manufacturing, Quality, Regulatory, and external CDMO partners. Regular collaboration with colleagues based at the company's Boston headquarters is expected through virtual meetings and periodic onsite visits.
Position Summary
The successful candidate will lead process development and technology transfer activities supporting the advancement of radiopharmaceutical programs from development through clinical manufacturing. This is an excellent opportunity for a hands-on scientist with experience in radiopharmaceutical manufacturing, GMP environments, and external partner management who is looking to make a significant impact within a growing organisation.
About the Opportunity
Key Responsibilities
- Develop and optimise radiopharmaceutical production processes to support pipeline advancement.
- Transition early-stage manufacturing processes into GMP-ready manufacturing processes.
- Design and execute process development strategies, including qualification, verification, and validation activities.
- Lead technology transfer activities at internal manufacturing sites and external CDMO partners.
- Act as the primary technical contact during process transfers and manufacturing implementation.
- Deliver technical training and support to manufacturing personnel.
- Author and review Master Batch Records, development reports, technology transfer documents, qualification protocols, validation reports, and regulatory submission content.
- Support deviation, OOS, and OOT investigations, including root cause analysis and CAPA implementation.
- Ensure compliance with cGMP, GLP, data integrity, and regulatory requirements.
- Collaborate with Manufacturing, Quality, Regulatory Affairs, CMC, and external partners to meet development timelines.
Qualifications
- PhD in a relevant scientific discipline with 4 years of experience, MSc with 8 years, or BSc with 10 years.
- Hands-on experience working with radioactive materials.
- Demonstrated experience in radiopharmaceutical process development and manufacturing.
- Strong understanding of cGMP principles and GMP manufacturing operations.
- Technology transfer experience within a pharmaceutical or radiopharmaceutical environment.
- Excellent technical writing skills.
- Experience working cross-functionally and managing external partners.
- Strong communication, organisational, and project management skills.
- High attention to detail and commitment to quality and compliance.
Preferred Experience
- Radioligand therapy or radiopharmaceutical drug development experience.
- CDMO management experience.
- Experience supporting IND and IMPD submissions.
- Knowledge of process validation and lifecycle management.
- Experience with chromatography systems, LIMS, and related manufacturing technologies.
What's on Offer
- Opportunity to join a growing leader in radiopharmaceutical development.
- High level of scientific ownership and visibility.
- Collaborative and innovative culture.
- Competitive compensation package aligned to experience and level.