Senior Manager, Radiochemist - CMC

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is an established molecular imaging company on a growth trajectory to provide innovative, well differentiated diagnostics solutions, informing patients and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by its management expertise and agility, supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals.

Blue Earth Diagnostics’ clinical focus is exclusively in cancer, with an expanding pipeline in disease states. Blue Earth Diagnostics’ strategy is to apply its knowledge and expertise to developing promising cancer radiopharmaceuticals for imaging.

Reporting to the Senior Director, PET Operations (Molecular Imaging Platform), the Senior Manager, Radiochemist - CMC will be responsible for overseeing the daily operations of Blue Earth Diagnostics’ U.S.

-based third-party Contract Manufacturing Organization (CMO) network. This role will also play a key part in shaping and expanding the company’s domestic PET Manufacturing Facility (PMF) footprint. The position requires strong leadership, operational oversight, and cross-functional collaboration to ensure consistent, high-quality production and supply of PET radiopharmaceuticals.

CMO Network Oversight:

• Manage daily batch production across the CMO network.
• Rapidly address synthesis or logistics issues to minimize disruptions.
• Communicate supply interruptions to field stakeholders promptly.
• Monitor and follow up on quality issues that may impact site performance.
• Evaluate product demand relative to site capacity and adjust plans accordingly.
• Track and analyze key performance indicators (KPIs) for each CMO.

Project & Stakeholder Management:

• Support development projects with third-party manufacturers and coordinate implementation at the site level.
• Serve as the primary liaison between Blue Earth Diagnostics and CMO technical teams, providing technical support during site setup and post-approval phases.
• Lead and coordinate technology transfer activities from development to commercial manufacturing at CMO sites.
• Ensure robust documentation, knowledge sharing, and training during the transfer process.
• Collaborate with R&D, Quality, and Regulatory teams to ensure seamless integration of new products or processes into manufacturing.
• Monitor post-transfer performance and troubleshoot any issues to ensure process consistency and compliance.
• Maintain detailed records of transfer protocols, validation activities, and lessons learned for continuous improvement.

Supply Chain & Quality

Collaboration:

• In partnership with the Supply Chain Manager, oversee the supply and resupply of production materials to sites and depots.
• Forecast usage of production consumables and recommend resupply strategies.
• Collaborate with CMOs on deviations, investigations, and corrective actions.
• Lead regular meetings with CMOs and internal teams, ensuring documentation is maintained.
• Work cross-functionally with departments such as Sales, Marketing, and Analytics to assess changes in supply and demand.
• Proactively identify supply chain risks and implement corrective actions.
• Maintain a strong understanding of both internal and CMO quality systems.
• Participate in quality and due diligence audits of CMOs and external suppliers as needed.
• Perform additional duties as assigned by management.

• Science degree in a chemistry discipline, or a related field.

• Bachelor’s Degree in a Life Sciences discipline required.
• Minimum 5-years’ experience managing 3rd party CMO’s.
• Minimum 5-years’ experience in aseptic manufacture, preferably in a PET radiopharmaceuticals environment.
• Thorough understanding of cGMP’s is required - experience with production of Investigational Medicinal Product (IMP’s) is a plus.
• Familiar with all aspects of a quality system, oversight and risk management. Prior experience with 21
  
  CFR Parts 211 & 212 is strongly desired.
• Experience in consolidating and analyzing data; and producing…