Associate Director, Radiopharmaceutical Development

2 weeks ago

Cambridge, United States Artbio Full time

This leader will be responsible for developing our Pb212 drug candidates from the beginning to the end of their clinical trials. He or she will be responsible for setting up the technical transfers necessary to support clinical trials. An expert thinker with technical proficiency in radiopharmaceuticals will be the successful candidate, who will build a fresh platform paradigm focusing on Pb212. Radio metal chemistry, radio-formulation development analytical expertise, CMC writing and the ability to integrate learnings and failures from others are some things the lead must have.

Main Duties and Responsibilities

* Establish a robust development protocol and validation plan for the platform, spanning from the preclinical stage to the clinical scale-up stage.
* Establish a comprehensive technical process for Pb212-drug candidates to facilitate the transfer and management of a productive manufacturing process to our CDMOs. This process encompasses the identification and implementation of appropriate manufacturing and quality control procedures, equipment, and facilities.
* Enhance internal technical and operational capabilities to develop the platform, including ongoing monitoring, enhancement, and troubleshooting in the scope of process manufacturing and process control, including quality assurance and release time.
* Organize, manage, execute technology transfer to CDMOs.
* Build the KPI scorecards to monitor CDMOs performance, troubleshooting.
* Continuous improvements to reach manufacturing efficiency >90%
* Select and qualify suitable raw materials and ingredients that conform to regulatory requirements.
* Develop an operational excellence mindset to develop a fast process of manufacturing and quality control to handle the shelf life of Pb212.
* Co-write the dossier with the CMC.
* Establish procedures for good manufacturing practices, safety, reliability, and a commitment to excellence.
* Consider the continuous evolution of the platform from preclinical to clinical when designing new R&D spaces.
* Development formulation from preclinical to clinical phase in accordance to FDA and EMEA guidance
* Motivate and steer a group of radiopharmaceutical advancements in executing the technical and operations tactical plan, ensuring that projects are delivered on schedule, within budget, and in line with the required high-quality standards.
* Improve the ARTBIO process by identifying, integrating, and improving on learnings from experience in Pb212 generators and drug candidate manufacturing.
* 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 procedures that improve effectiveness, decrease expenses, and improve the security and reliability of the radiopharmaceuticals offered by ARTBIO.
* Communicate effectively with all stakeholders, including management, clients, vendors, and regulatory bodies, to make sure everyone understands the company's strategic goals and objectives.
* Keep up with the latest technological advancements and market developments in the field of alpha radio ligand therapy development and offer direction to the top management team on how ARTBIO can take advantage of these developments to boost its competitive edge.

Qualifications & Experience Required

* PharmD, PhD in Radio-Chemistry, 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.
* Demonstrated experience in developing and operating complex technologies, ideally in the field of radio ligand therapy.
* 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 in particular preclinical and safety 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.

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