ARTBIO

Biotechnology

AssociateDirector,RadiopharmaceuticalDevelopment

Cambridge, Massachusetts, United States FULL TIME Remote Friendly
The Brief

“Associate Director, Radiopharmaceutical Development at ARTBIO. Skills: Radiopharmaceutical development, Radiolabeling, Formulation development, Process development. Drive radiopharmaceutical development. Design radiolabeling synthesis”

What You'll Achieve.

Timely data packages for regulatory submissions; Compliance with regulatory standards; Alignment with corporate objectives; Support clinical trials; Robust and in control process; Enhance internal technical and operational capabilities; Improve operational efficiencies; Deliver high-quality results within tight deadlines; Ensure compliance with all relevant regulations

Industry & Context.

Biotechnology
Problems you'll solve

Problem-solving skills; Troubleshooting

Eligibility Requirements

Willingness to work extended hours, Willingness to travel within the country, Willingness to travel outside the country

What They're Looking For.

Must Have

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, technical knowledge and problem-solving skills in formulation, radiolysis, process validation, qualification of synthesis module, RadioTLC, RadioHPC, Germanium detector, and radiopharmaceuticals, 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 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, Written and verbal fluency in English

Nice to Have

Passion to explore novel new technologies related to RLT development

What You'll Do.

Drive radiopharmaceutical development

Design radiolabeling synthesis

Design process development

Troubleshoot manufacturing process

Ensure timely data packages

Support clinical trials

Lead radiolabeling development

Lead formulation development

Lead analytical method development

Organize technology transfer

Manage technology transfer

Execute technology transfer

Oversee technical development

Monitor production data

Monitor analytical data

Enhance internal capabilities

Troubleshoot platform

Develop future products

Qualify raw materials

Develop project plans

Collaborate with stakeholders

Improve operational efficiencies

Monitor CDMO performance

Develop formulation preclinical

Develop formulation clinical

Develop relationships

Maintain relationships

How You'll Work.

Team & Collaboration

Collaborate with multidisciplinary team of CDMOs; Collaborate with senior leaders; Collaborate with internal and external stakeholders; Collaborate with research and development; Collaborate with pre-clinical and clinical teams; Collaborate with quality control teams; Collaborate with quality assurance teams; Collaborate with regulatory teams; Foster collaboration; Build working relationships

Communication Scope

Communicate effectively; Interpersonal skills; Communication skills; Verbal fluency; Written fluency

Process & Methodology

Project management, Prioritize tasks, Multitask effectively, Manage multiple priorities

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