Associate Director, Radiopharmaceutical Development

Job Description

Job Description

Summary

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.

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.

Qualifications & Experience

About Us

ARTBIO is a clinical-stage radiopharmaceutical company redefining cancer care by creating a new class of alpha radioligand therapies (ARTs). The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs with lead program AB001 currently in first in human trials. ARTBIO is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital. For more information, visit www.artbio.com, and follow us on LinkedIn and Twitter.

As an emerging, global biotech with locations in Boston, Massachusetts, Basel, Switzerland, London, England and Oslo, Norway, we take advantage of diverse scientific depth and insights which makes ARTBIO a unique place to work.  We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration.

EEO Statement

ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

ARTBIO does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to unsolicited resumes.