Associate Director, Radiopharmaceutical Development

ARTBIO • Cambridge, MA

97d

About The Position

As part of ARTBIO’s CMC team, the Associate Director will drive the radiopharmaceutical development of Radioligand Therapy (RLT) products by designing radiolabeling synthesis, formulation, and process development. This role will collaborate with a multidisciplinary team of CDMOs (Contract Drug Manufacturing Organizations) to troubleshoot the manufacturing process of our lead products, ensuring timely data packages for regulatory submissions in compliance with regulatory standards and aligned with corporate objectives. The candidate will also be responsible for setting up the technical transfers necessary to support clinical trials. The ideal candidate is an expert thinker with attention to detail in manufacturing data analysis, high technical proficiency in radiopharmaceutical development, and demonstrated experience with radio metal chemistry, formulation development, and analytical expertise.

Requirements

• 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.
• 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.

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.
• 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.

What This Job Offers

• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 51-100 employees