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ABOUT CURIUM
The Group Curium is the world’s largest nuclear medicine company with over 1,2+ B € revenues. At Curium, we have a singular focus – to develop, manufacture and supply world-class radiopharmaceutical products around the globe. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 15 million patients annually. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. As a fast-growing company in a niche market, Curium is today owned by a private equity fund with LBO financing scheme.
Building on its unique strengths across radiopharmaceutical product manufacturing, logistics and commercialization, and led by an agile, LBO-driven leadership team, Curium has already achieved a critical mass and is the largest player in the nuclear medicines field. This is one that has become increasingly dynamic and innovative in recent years.
Summary of Position
The Director, Early Development CMC will provide strategic regulatory and technical leadership for Chemistry, Manufacturing, and Controls (CMC) activities supporting early-stage biologic and radioligand therapeutic and diagnostic programs. This individual will partner closely with cross-functional CMC teams responsible for advancing novel oncology candidates from preclinical development through First-in-Human (FIH) and early clinical proof-of-concept studies through BLA / NDA filing.
The role requires experience in biologics development or small molecule development drug product formulation, analytical development, and regulatory CMC requirements. The Director will serve as the Regulatory CMC representative on multidisciplinary program teams and ensure development activities support aggressive clinical timelines while maintaining compliance with global regulatory expectations.
Essential Functions
Key Responsibilities
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Regulatory CMC Strategy
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- Develop and execute integrated CMC development strategies supporting early clinical programs through registration.
- Define CMC regulatory milestones aligned with overall program objectives.
- Establish phase-appropriate manufacturing and control strategies.
- Provide inputs to technical risk assessments and mitigation plans.
- Provide strategic leadership and lead the preparation of key regulatory documents including IMPD/ Module 3 sections.
- Support interactions with FDA, EMA, MHRA, and other global regulatory agencies.
Requirements
Education
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- PhD, MS, or BS in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biology, Chemistry, or related discipline.
- Advanced degree preferred.
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Experience
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- 10–15 years of pharmaceutical or biotechnology industry experience.
- Significant CMC development experience supporting biologics and small molecule development.
- Experience advancing products from discovery through Phase 1/2 clinical development. Experience filing BLA.
- Experience authoring regulatory CMC documentation.
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Preferred:
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- Antibody-based therapeutics.
- ADCs or targeted biologics.
- Oncology drug development.
Competencies
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