Senior Manager, CMC Radiopharmaceuticals

Thor Companies; New Jersey; Vor Ort; USD 140.000 - 160.000; Vollzeit

Zusammenfassung

A leading company in the pharmaceutical sector is seeking a Senior Manager, CMC Radiopharmaceuticals to oversee crucial manufacturing processes and ensure compliance with regulatory standards. The position involves strategic management of CDMO relationships and development of manufacturing workflows. Ideal candidates will possess an advanced degree and extensive experience in radiopharmaceuticals.

Qualifikationen

• Advanced degree in relevant field required.
• Experience in radiopharmaceutical sector (5+ years) necessary.
• Skills in regulatory content development and compliance expected.

Aufgaben

• Lead evaluation of CDMOs and technical strategy for RPT candidates.
• Design manufacturing workflows and quality control systems.
• Manage technology transfer initiatives and supplier relationships.

Kenntnisse

Strategic thinking

Collaborative skills

Regulatory knowledge

Communication skills

Ausbildung

PharmD or PhD in Radiochemistry, Chemical Engineering or related life science

Jobbeschreibung

Senior Manager, CMC Radiopharmaceuticals

Senior Manager, CMC Radiopharmaceuticals

3 days ago Be among the first 25 applicants

This range is provided by Thor Companies. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$140,000.00/yr - $160,000.00/yr

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Responsibilities

• Lead the evaluation and selection of Contract Development and Manufacturing Organizations (CDMOs) and establish a comprehensive technical strategy to support the successful transfer and oversight of manufacturing processes for Radiopharmaceutical Therapy (RPT) candidates.
• Design and implement effective manufacturing workflows, quality control systems, equipment setups, and facility standards to ensure operational efficiency and regulatory compliance.
• Manage end-to-end technology transfer initiatives to and between CDMO partners, ensuring alignment with technical and regulatory expectations.
• Critically review technical manufacturing and analytical documentation provided by CDMOs—such as batch records, Certificates of Analysis (CoA), specifications, protocols, and reports—to ensure accuracy, completeness, and compliance.
• Direct the selection, qualification, and approval of raw materials, packaging materials, and shipping solutions in accordance with regulatory guidelines. Cultivate and manage relationships with key suppliers and external service providers to ensure consistent supply chain performance.
• Ensure adherence to all applicable regulatory, quality, safety, and environmental requirements across outsourced manufacturing, internal R&D activities, and company-led projects.
• Contribute to the authorship of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory submissions, including INDs, IMPDs, and periodic reports.
• Act as a central point of contact for communication among internal stakeholders, senior leadership, CDMOs, and other external collaborators.
• Monitor industry trends and emerging technologies in the alpha radioligand therapy space and provide strategic recommendations to the executive team.

Qualifications

• Advanced degree (PharmD, PhD) in Radiochemistry, Chemical Engineering, Radiopharmaceutical Sciences, or a related life science discipline.
• At least 5 years of relevant experience in the radiopharmaceutical sector, with a strong emphasis on manufacturing operations and process development.
• In-depth knowledge of formulation development, radiolysis control, process validation, synthesis module qualification, and analytical methodologies.
• Demonstrated strategic thinking and strong collaborative skills, particularly in cross-functional settings involving preclinical and safety teams.
• Solid understanding of regulatory frameworks and compliance standards, including those set by the FDA, EMA, and other global regulatory agencies.
• Hands-on experience with CMC content development for regulatory filings and drug development processes.
• Well-versed in current regulatory expectations for therapeutic product development in both the US and EU.
• Exceptional communication skills in English, both written and verbal.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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