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Associate Director, Radiopharmaceutical Development
ARTBIOAssociate Director driving the radiopharmaceutical development of RLT products at ARTBIO. Designing synthesis, formulation, and process development while collaborating with CDMOs and stakeholders.
About the role
Key responsibilities & impact- Drive the radiopharmaceutical development of Radioligand Therapy (RLT) products by designing radiolabeling synthesis, formulation, and process development.
- Collaborate with a multidisciplinary team of CDMOs (Contract Drug Manufacturing Organizations) to troubleshoot the manufacturing process of lead products.
- Ensure timely data packages for regulatory submissions in compliance with regulatory standards and aligned with corporate objectives.
- Responsible for setting up the technical transfers necessary to support clinical trials.
- Monitor the production and analytical data of CDMOs to ensure the process is robust and in control.
- Collaborate with internal and external stakeholders, including research and development, pre-clinical and clinical, to drive project success.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Equal opportunity workplace
- Affirmative action employer
- Remote work option
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
radiolabeling synthesisformulationprocess developmentGMP environmentsprocess validationqualification of synthesis moduleRadioTLCRadioHPCGermanium detectorradiopharmaceuticals
Soft Skills
problem-solvingorganizational skillsproject managementinterpersonal skillscommunication skillsleadershipcollaborationautonomymultitaskingattention to detail
Certifications
PhD in RadiochemistryPhD in Chemical EngineeringPhD in Radiopharmaceuticals