• Serve as the primary point of contact and key liaison between the company and external manufacturing partners, particularly those involved in radiotracer production
• Cultivate and maintain strong, effective relationships with external manufacturing sites to ensure consistent, high-quality production and compliance.
• Lead and participate in regular business reviews, aligning the external manufacturers27 performance with corporate goals, and addressing any issues proactively. Safety & Compliance:
• Ensure all external manufacturing operations adhere to safety regulations, particularly in the production of radiotracers, and comply with environmental, health, and safety (EHS) guidelines.
• Monitor and enforce compliance with 21 CFR 212 (for the production of radiopharmaceuticals), FDA regulations, and other relevant guidelines, ensuring all manufactured radiotracers meet stringent regulatory standards.
• Oversee adherence to the Board of Pharmacy regulations, particularly with respect to radiopharmacies and the handling of radiopharmaceuticals.

Quality & Delivery Assurance:

• Manage the quality assurance processes to ensure the consistent production of high-quality radiotracers in compliance with GMP, FDA, and other regulatory requirements
• Ensure timely and accurate delivery of radiotracers, working with external manufacturers to address any issues related to production delays or capacity.
• Collaborate with the quality assurance team to resolve deviations, implement corrective and preventive actions, and continuously improve quality control processes.

Speed & Cost Management:

• Optimize manufacturing processes to balance speed-to-market needs with cost-effectiveness, particularly for the production of radiopharmaceutical products.
• Work closely with external manufacturers to drive cost-saving initiatives while maintaining high quality and compliance standards.
• Ensure that external manufacturing costs are managed effectively, including negotiating pricing and terms with vendors to align with the company27s financial objectives.

Risk Management:

• Proactively identify and mitigate risks related to external manufacturing operations, including production, regulatory compliance, and supply chain risks, especially with radiotracers.
• Develop and implement contingency plans to address potential disruptions in radiotracer production, supply chain issues, or regulatory changes.  Cross-functional Collaboration:
• Collaborate with internal teams, including Supply Chain, Operations, Regulatory Affairs, and R&D, to ensure alignment and smooth operations across external manufacturing activities.
• Provide leadership and regular updates to senior management on the performance of external manufacturers, focusing on key issues, risks, and solutions.

Performance Metrics:

• Define, monitor, and report on key performance indicators (KPIs) for external manufacturing performance, ensuring alignment with business goals for radiotracer production.
• Track and report on the performance of external partners to drive continuous improvement in quality, safety, cost, speed, and compliance.

• Bachelor27s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Chemistry, or related field; advanced degree (e.g., MBA, Master27s in Supply Chain, or similar) preferred.
• Experience: 8+ years of experience in external manufacturing or operations management within regulated industries such as pharmaceuticals, biotechnology, or radiopharmaceuticals.
• Proven track record in managing relationships with multiple external manufacturing sites, including contract manufacturing organizations (CMOs).
• Solid experience in quality management, compliance, and driving continuous improvements in manufacturing operations, particularly in regulated environments.
• Demonstrated success in optimizing production processes for speed and cost while maintaining high regulatory standards.

Desired Qualifications:

• In-depth experience with radiotracers, radiopharmacies, and 21 CFR 212 regulations, including handling and production of radiopharmaceuticals.
• Extensive knowledge of 21 CFR 212, FDA regulations, and GMP as they apply to radiopharmaceuticals and external manufacturing.
• Strong understanding of radiopharmacy operations, Board of Pharmacy requirements, and the handling of radiotracers in accordance with industry standards.
• Strong leadership, interpersonal, and communication skills to effectively manage cross-functional teams and external partners.
• Excellent problem-solving, negotiation, and conflict resolution skills.
• Ability to analyze complex data, identify areas for process improvement, and implement actionable solutions.
• Familiarity with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
• Proven ability to manage multiple projects simultaneously and prioritize tasks effectively.
• Strong knowledge of SAP, Oracle, or other ERP systems is a plus.
• Experience in managing global manufacturing operations, particularly in the production of radiotracers.
• Prior experience working in a radiopharmaceutical company or a similar regulated manufacturing environment.
• Certification in quality management or project management is a plus.