ARTBIO
Biotechnology
AssociateDirector,RadiopharmaceuticalDevelopment
“Associate Director, Radiopharmaceutical Development at ARTBIO. Skills: Radiopharmaceutical development, Radiolabeling, Formulation development, Process development. Drive radiopharmaceutical development. Design radiolabeling synthesis”
What You'll Achieve.
Timely data packages for regulatory submissions; Compliance with regulatory standards; Alignment with corporate objectives; Support clinical trials; Robust and in control process; Enhance internal technical and operational capabilities; Improve operational efficiencies; Deliver high-quality results within tight deadlines; Ensure compliance with all relevant regulations
Industry & Context.
Problem-solving skills; Troubleshooting
Willingness to work extended hours, Willingness to travel within the country, Willingness to travel outside the country
What They're Looking For.
Must Have
PhD in Radiochemistry, Chemical Engineering, Radiopharmaceuticals, or related fields within life sciences, Minimum of 5 years of experience in the radiopharmaceutical field, with a focus on manufacturing and process development, Experience and familiarity with GMP environments and radiopharmaceutical manufacturing processes, Demonstrated experience in developing and operating complex technologies, ideally in the field of radio ligand therapy (RLT), Experience managing a team of technical persons and scientists, with a track record of delivering projects on time, within budget, and to the required safety and quality standards, technical knowledge and problem-solving skills in formulation, radiolysis, process validation, qualification of synthesis module, RadioTLC, RadioHPC, Germanium detector, and radiopharmaceuticals, Excellent organizational and project management skills, with the ability to prioritize and multitask effectively, Familiarity with relevant regulations (FDA, EMA), standards, and guidelines, including those relating to quality, safety, and environmental impact, Excellent know-how on regulatory requirements related to drug development, Exceptional interpersonal and communication skills with a proven ability to lead teams, foster collaboration, and build working relationships, Capacity to work autonomously, manage multiple priorities, and deliver high-quality results within tight deadlines, Highly organized with commitment to precision, quality, and compliance in all aspects of work, Written and verbal fluency in English
Nice to Have
Passion to explore novel new technologies related to RLT development
What You'll Do.
Drive radiopharmaceutical development
Design radiolabeling synthesis
Design process development
Troubleshoot manufacturing process
Ensure timely data packages
Support clinical trials
Lead radiolabeling development
Lead formulation development
Lead analytical method development
Organize technology transfer
Manage technology transfer
Execute technology transfer
Oversee technical development
Monitor production data
Monitor analytical data
Enhance internal capabilities
Troubleshoot platform
Develop future products
Qualify raw materials
Develop project plans
Collaborate with stakeholders
Improve operational efficiencies
Monitor CDMO performance
Develop formulation preclinical
Develop formulation clinical
Develop relationships
Maintain relationships
How You'll Work.
Team & Collaboration
Collaborate with multidisciplinary team of CDMOs; Collaborate with senior leaders; Collaborate with internal and external stakeholders; Collaborate with research and development; Collaborate with pre-clinical and clinical teams; Collaborate with quality control teams; Collaborate with quality assurance teams; Collaborate with regulatory teams; Foster collaboration; Build working relationships
Communication Scope
Communicate effectively; Interpersonal skills; Communication skills; Verbal fluency; Written fluency
Process & Methodology
Project management, Prioritize tasks, Multitask effectively, Manage multiple priorities
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