Director, External Manufacturing & Supply

Location

Cambridge, MA | United States

Job description

Summary

We are seeking a Director of External Manufacturing & Supply who will be responsible for leading and coordinating overall CMO external operations for generator, source holder and finished products. You will have complete accountability for all external manufactured/purchased finished products, APIs and isotope across the value chain. You will also oversee the supplier teams, and is 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 ensure the implementation of strategic, tactical, and operational plans within the manufacturing network to meet clinical and commercial requirements, ensuring timely supply readiness of products to patients, whilst optimizing the value chain. Steers strategic external value chain suppliers in the area of isotopes and CMOs. Leads external operations and supports initiatives for business enhancement and performance management. This is a wonderful opportunity to join our growing Technical Operations organization and drive operational governance, projects and process improvements.

Responsibilities

• 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 & Experience

• 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.

About Us

ARTBIO is re-defining cancer care by developing a new class of radioligand therapies (RLT) which harness the power of 212Pb and deliver it directly to the tumors. Targeted RLT is one of the fastest growing areas of oncology research and investment. The foundational technology, termed AlphaDirect, was born out of elegant research by our scientific founders, Roy Larsen and Øyvind Bruland, inventors of XofigoTM. ARTBIO is leveraging this groundbreaking science and expediting novel Drug Discovery targets which broadly exploit the unmet medical need and opportunity in revolutionizing cancer care. Supported by a committed investment board including Omega Funds, F-Prime Capital, Radforsk and Third Rock Ventures, ARTBIO has built a highly experienced, multi-disciplinary team of drug-hunters and developers. For more information on our strategy and emerging pipeline, please visit and follow-us on  LinkedIn .

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.

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