Associate Director, Radiopharmaceutical Development
- 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
- 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
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