Senior Manager, Radiochemist - CMC - Blue Earth Diagnostics Inc

About Blue Earth Diagnostics: 

Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.

Job Purpose

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.

Main Responsibilities, Activities, Duties and Tasks

• 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.
• Technology Transfer
  • 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.
• Risk Management & Compliance
  • 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.

Education

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

Professional Experience, Knowledge & Technical Skills

• 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 21CFR Parts 211 & 212 is strongly desired.
• Experience in consolidating and analyzing data; and producing appropriate reports that reflect key performance metrics of assigned CMO’s.
• Some domestic travel is required (up to 30%) with occasional international travel.
• Demonstrated ability to develop self; build high performance teams and develop others.
• Qualified candidate must be legally authorized to be employed in the United States.
• Excellent oral & written communication skills.  Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Strong coaching, facilitation, and organizational skills; team player. Experience and skills with cross-functional and highly matrixed organizations. 

How to Apply:

Please submit an application and include your CV and a cover letter outlining:

• Why this role appeals to you.
• How your background and skills are suited to this role.

Why Blue Earth Diagnostics?

We are seeking motivated individuals with drive and determination to succeed in an innovative and respectful team environment. Our employees are empowered to achieve great things and thrive in our exceptionally co-operative culture. As a young and dynamic company experiencing rapid growth, BED prides itself on providing a clear focus and incentives to achieve our business-critical objectives. We aim to have fun and celebrate each milestone along the way.

Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. We provide a comprehensive benefits package including a complete healthcare plan, 401k with matching, promote work/life harmony, and generous paid holidays.

Blue Earth Diagnostics is an equal opportunity employer.  All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law.

Annual Salary: $130,000.00-$145,000.00

Why Blue Earth Diagnostics?
 

We are seeking motivated individuals with drive and determination to succeed in an innovative and respectful team environment. Our employees are empowered to achieve great things and thrive in our exceptionally co-operative culture. As a young and dynamic company experiencing rapid growth, Blue Earth Diagnostics prides itself on providing a clear focus and incentives to achieve our business-critical objectives. We aim to have fun and celebrate each milestone along the way. 

If you are seeking a job where you have a clear impact on business success, are working with talented and collaborative colleagues daily, and are doing something great for human healthcare, then this job is for you.

Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. We also offer a comprehensive benefits package including a complete healthcare plan, 401k with matching, work/life harmony, and generous paid holidays.

Blue Earth Diagnostics is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law.