ARTBIO · 4 months ago
Associate Director, Radiopharmaceutical Development
Cambridge, MA
Full-time
Hybrid
Senior Level
5+ years expARTBIO is a clinical-stage radiopharmaceutical company redefining cancer care through innovative alpha radioligand therapies. The Associate Director will lead the development of Radioligand Therapy products, collaborating with CDMOs to ensure compliance with regulatory standards and supporting clinical trials.
BiotechnologyHealth CareHospitalMedicalMedical DevicePharmaceutical
Responsibilities
Lead radiolabeling, formulation, and analytical method development of small molecules and peptides with different chelators and radiometals
Organize, manage, and execute technology transfer to CDMOs
Oversee the technical development of ARTBIO’s products with CDMOs
Direct the internal ARTBIO team and CDMO teams in generating comprehensive CMC data packages in compliance with regulatory requirements, ensuring a seamless regulatory submission
Monitor the production and analytical data of CDMOs to ensure the process is robust and in control
Enhance internal technical and operational capabilities to develop the platform, including ongoing monitoring, enhancement, and troubleshooting, and future product development
Select and qualify suitable raw materials and ingredients that conform to regulatory requirements
Collaborate with senior leaders to develop project plans, timelines, budgets, and teams in alignment with the company’s goals
Collaborate with internal and external stakeholders, including research and development, pre-clinical and clinical, quality control, quality assurance, and regulatory teams to drive project success
Identify and implement methods and cutting-edge technologies to enhance processes and improve operational efficiencies in radiopharmaceutical development. Offer direction to the top management team on how ARTBIO can competitively leverage these developments
Build the KPI scorecards to monitor CDMO performance and troubleshooting
Development formulation from preclinical to clinical phase in accordance with FDA and EMEA guidance
Establish procedures for good manufacturing practices, safety, reliability, and a commitment to excellence
Develop and maintain relationships with key suppliers and service providers to ensure the reliable and efficient supply of raw materials, equipment, and services
Ensure compliance with all relevant regulations, standards, and guidelines, including those relating to quality, safety, and environmental impact for our CDMOs, internal R&D, and own projects
Qualification
Required
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
Strong technical knowledge and problem-solving skills in formulation, radiolysis, process validation, qualification of synthesis module, RadioTLC, RadioHPC, Germanium detector, and radiopharmaceuticals, with the ability to think strategically and communicate effectively with cross-functional colleagues
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 strong 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
Willingness to work extended hours as needed to meet project demands
Passion to explore novel new technologies related to RLT development
Willingness to travel within the country and outside the country
Written and verbal fluency in English
Company
ARTBIO
ARTBIO is a clinical-stage radiopharmaceutical biotechnology business that is working to create a new class of alpha radioligand medicines.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$245MKey Investors
Third Rock VenturesF-Prime
2025-07-29Series B· $132M
2023-12-07Series A· $90M
2023-06-21Seed· $23M
Leadership Team
Emanuele Ostuni
Founding CEO
Øyvind Sverre Bruland
Co-Founder
Recent News
2026-01-06
Company data provided by crunchbase