Job Description Summary

We are seeking a highly skilled and experienced External Manufacturing Leader to oversee and manage relationships with external manufacturing partners across various sites, specifically those involved in the production of radiotracers. The ideal candidate will have a deep understanding of regulatory frameworks, including 21 CFR 212, and familiarity with radiopharmaceuticals, radiopharmacies, and Board of Pharmacy requirements. This role will focus on ensuring safety, quality, compliance, delivery, speed, and cost across these manufacturing sites while managing the complexities of radiotracer production.

Job Description

Roles & Responsibilities:

• 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 manufacturers’ 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 company’s 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.

Required Qualifications:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Chemistry, or related field; advanced degree (e.g., MBA, Master’s 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.