Job PurposeReporting 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.
Annual Salary: $130,000.00-$145,000.00
