Executive Director, Head of Technical Operations (CMC, Product Development & Manufacturing)

Job Description

Location: New York, NY (Hybrid)

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Reporting to: CSO

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Why This Role. Why Now.

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Radiopharmaceuticals are one of the fastest growing and most strategically active segments in biotech, and Actinium Pharmaceuticals is at the forefront of targeted radiotherapy innovation. This leadership role offers the opportunity to build and scale a world-class Technical Operations organization, leading CMC strategy, manufacturing, product development, regulatory execution, and commercialization readiness.

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The Opportunity

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Actinium is seeking an accomplished leader to head Technical Operations across CMC, process development, manufacturing, quality partnership, regulatory CMC, and supply chain. You will oversee the strategy and execution of drug product development from early development through commercialization while leading the operation of a new radiopharmaceutical manufacturing facility. This is a highly visible cross-functional leadership role with responsibility for building organizational capability and enabling successful clinical programs.

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Key Responsibilities

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• Develop and execute the overall CMC strategy across antibody radioconjugate and radiopharmaceutical R&D programs, ensuring alignment with corporate objectives, clinical milestones, and commercialization plans.
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• Build and lead a high-performing Technical Operations organization, fostering a culture of collaboration, accountability, innovation, and operational excellence.
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• Serve as a key member of the leadership team, partnering with Research, Clinical Development, Regulatory, Quality, Finance, Business Development, and Executive Leadership to drive strategy and cross-functional execution.
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• Lead integrated biologics and radiopharmaceutical CMC regulatory strategy, support global regulatory submissions, including INDs and BLAs, and represent Technical Operations in interactions with FDA and international health authorities.
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• Oversee end-to-end process development and manufacturing of antibody radioconjugates and radiopharmaceuticals, including antibody production and purification, conjugation, radiolabeling, formulation, technology transfer, process validation, and commercial readiness.
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• Provide strategic oversight of global biologics and radiopharmaceutical CDMOs, manufacturing partners, and supply chain to ensure compliant, reliable, and timely delivery of clinical and commercial supply.
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• Lead the staffing, qualification, and operational readiness of Actinium's radiopharmaceutical manufacturing facility, including production planning and GMP operations.
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• Oversee GMP documentation, quality systems, and inspection readiness, including SOPs, specifications, batch records, validation protocols, and technical reports.
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• Establish and manage critical process parameters (CPPs), critical quality attributes (CQAs), product specifications, comparability strategies, and lifecycle management across biologics and radiopharmaceutical manufacturing.
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• Develop integrated project plans, resource forecasts, and risk mitigation strategies to ensure timely execution of corporate milestones.
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• Drive continuous improvement in manufacturing processes, operational efficiency, and technical capabilities.
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• Manage departmental budgets and resources, and communicate technical strategy, program progress, and key risks to Executive Leadership, the Board of Directors, and external stakeholders.
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What You Bring

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• MS or PhD in Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or a related scientific or engineering discipline.
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• 15+ years of progressive CMC leadership experience within the pharmaceutical or biotechnology industry, with responsibility across biologics and radiopharmaceutical CMC, process development, manufacturing, technical operations, and product lifecycle management.
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• Demonstrated success developing and executing integrated CMC strategies that have advanced antibody-based biologics, antibody radioconjugates, and radiopharmaceutical products from early development through clinical and commercial manufacturing, including global regulatory submissions and health authority interactions.
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• Extensive expertise in antibody biologics manufacturing (including mammalian cell culture, purification, formulation, and fill-finish) and radiopharmaceutical manufacturing, with experience in conjugation/radiolabeling interfaces, technology transfer, process characterization and validation, GMP manufacturing, commercialization readiness, and the design, commissioning, and operation of radiopharmaceutical manufacturing facilities.
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• Deep knowledge of cGMP regulations, biologics and radiopharmaceutical analytical characterization, stability, potency and comparability assessments, quality systems, supply chain management, and global regulatory requirements, including relevant ICH biologics guidance.
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• Proven ability to build, lead, mentor, and develop high-performing technical organizations while driving cross-functional collaboration across Research, Development, Regulatory, Quality, Clinical, Finance, and Executive Leadership.
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• Strong business acumen with experience managing departmental budgets, capital investments, organizational growth, strategic planning, and enterprise risk management.
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• Exceptional executive communication, leadership, organizational, negotiation, and problem-solving skills, with the ability to influence senior leadership, Boards of Directors, regulators, external partners, and investors.
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About Actinium Pharmaceuticals

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Actinium Pharmaceuticals develops targeted radiotherapies designed to improve outcomes for patients with cancer. The company is advancing a differentiated pipeline spanning solid tumors and hematologic malignancies while building world-class manufacturing capabilities.

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EEO & Benefits

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Actinium is an equal opportunity employer and offers competitive compensation, annual incentive opportunities, equity participation, 401(k), and comprehensive health benefits.