Vice President of CMC Operations
We are looking for a Vice President of CMC Operations responsible for technically designing, managing, and executing a plan for the use of Pb212 generators and the manufacturing of drug candidates in a network that can support clinical trials and can be ready for commercial deployment when it is decided by management. You must be a critical thinker who is also technically proficient in radiopharmaceutical and nuclear engineering by building a new platform paradigm focusing on Pb212. In addition, a deep understanding of the competitive landscape and the ability to integrate learnings and failures from others to improve the manufacturing process.
· Participate and promote a dedicated vision for technical operations, including a supply chain strategy that supports and enhances the company’s long-term plan.
· Develop an operational plan for developing Pb212 generators and drug candidates to transfer and manage an efficient manufacturing process to our CDMOs, including the identification and implementation of appropriate manufacturing processes, equipment, and facilities.
· Increase internal technical and operational capabilities to develop the platform including continuous monitoring, improvement and troubleshooting in the scope of process manufacturing, in process control including QC and release time.
· Build an operations GMP, HSE, Business continuity and quality culture.
· Design new facilities considering the constant evolution of the platform from preclinical to commercial level.
· Build, motivate and lead a department of CMC to execute the strategic plan, ensuring that projects are delivered on time, within budget, and to the required quality standards.
· Identify, integrate, and improve on learnings from experience in radioisotope generator and drug candidates manufacturing to improve the ARTBIO process.
· 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.
· Identify and implement process improvements to increase efficiency, reduce costs, and enhance the safety and quality of the products and services provided by ARTBIO.
· Support the approval of the company’s manufacturing sites and their compliance with GMP, HSE and QA standards.
Qualifications & Education
· PharmD, PhD in Chemistry, Chemical Engineering, Nuclear Engineering, Radiopharmaceuticals or related field.
· Minimum of 15years of experience in the radiopharmaceutical field, with a focus on manufacturing and process development.
· Demonstrated experience in developing and operating complex technologies, ideally in the field of radioligand therapy.
· Experience managing a team of engineers, pharmacists/qualified 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 nuclear physics, materials science and radiopharmaceuticals, with the ability to think strategically and communicate effectively with all stakeholders.
· 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.
· Familiarity with current US and EU regulatory requirements for therapeutic products.
· Written and verbal fluency in English.