Director of External Manufacturing & Supply Chain
We are seeking a Director of External Manufacturing and Supply Chainwho will be responsible for leading and coordinating overall CMO external operations for generator, source holder and finished products. You will have complete accountability for key external manufactured/purchased finished products, APIs and isotope across the value chain. You will also oversee the supplier teams, and are responsible for setting objectives, driving consistency of practices, ensuring all legal requirements are met. Delivers on the supply and cost objectives while ensuring full compliance and improving quality standards, through a motivated, engaged and empowered organization.
You will be at the core of the operations to ensure the implementation of strategic, tactical, and operational plans within the manufacturing network to meet clinical and commercial requirements, ensuring timely supply to patients, whilst optimizing the value chain. You will be steering strategic external value chain suppliers in the area of isotopes and CMOs. This is a wonderful opportunity to join our growing Technical Operations organization and drive operational governance, projects and process improvements.
· Develops and maintain relationship with key CMO and suppliers to ensure reliable and efficient supply of finished product to patients and across the value chain
· Leads the project management and coordination at the CMOs and is responsible for the implementation of the tactical and operational supply plans.
· Responsible for alignment between demand and supply (internal and external) to deliver Patient and Service level at targeted cost.
· Responsible for the Isotopes allocations and recommends the appropriate volume assigned to each network node. Participates in the strategic assessment and implementation of all steps of product manufacturing (isotope, source holder, generator and finished product manufacturing)
· Identify and implement process improvements at CMOs to increase efficiency, reduce costs, and enhance the safety, quality and business continuity of the products provided by ARTBIO.
· Support the approval of the company’s manufacturing sites and their compliance with GMP, HSE, transportation regulations and QA standards.
· Monitors external manufacturing performance and issues; ensures efficient bottleneck management and facilitates supply allocation in collaboration with the suppliers.
· Responsible for governing the supply chain activity at the network sites by supporting the teams in the definition and execution of the supply chain strategies, initiatives, prioritizing and resourcing appropriately, leveraging the internal and external Platform Network expertise and capabilities
Qualifications & Education
· Masters in Industrial Engineering, Chemistry, Chemical Engineering, Nuclear Engineering, Radiopharmaceuticals or related field.
· Minimum of 10 years of experience in the life sciences space (preferably radiopharmaceutical), with a focus on manufacturing and technical expertise and management of dangerous goods.
· Demonstrated experience in developing and operating complex technologies, ideally in the field of radioligand therapy; 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.
· Familiarity with relevant regulations (FDA, EMA), standards, and guidelines, including those relating to quality, safety, and environmental impact for radiopharmaceutical therapeutic products.
· Written and verbal fluency in English.
· Please note, this position will require at least 25% and must be based in Massachusetts.
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.
Questions and Application Process
If interested, please apply and send your CV to HR@artbio.com; All inquiries are treated confidentially.