Objective

Essential Functions

• Formulate an operational plan for the development of radioisotope and drug candidates, orchestrating a seamless transition to efficient manufacturing processes involving the identification and implementing optimal manufacturing methods, equipment, and facilities.
• Elevate internal technical and operational capabilities by implementing continuous monitoring, improvement, and troubleshooting protocols within the realm of process manufacturing, encompassing in-process control, QC, and release time.
• Foster a strong operational culture by establishing and reinforcing GMP and quality standards within the organization.
• Conceptualize new processes and facilities that accommodate the evolving platform, progressing from preclinical to commercial levels.

• Lead, inspire, and manage a CMC department, including engineers, pharmacists, and scientists, ensuring the timely delivery of projects within budget constraints while upholding safety and quality standards.

• Harness insights from experience in radioisotope generator and drug candidates manufacturing to enhance the company process continually.
• Cultivate and sustain relationships with key suppliers and service providers, ensuring a dependable and efficient supply chain for raw materials, equipment, and services.
• Ensure strict compliance with relevant regulations, standards, and guidelines, emphasizing quality, safety, and environmental impact across CDMOs, internal R&D, and proprietary projects.
• Identify and implement process improvements to enhance efficiency, reduce costs, and elevate the safety and quality of products and services provided.
• Provide essential support for the approval of the company’s manufacturing sites, ensuring adherence to GMP, HSE, and QA standards.

Qualifications

Education/Experience

• PharmD or a PhD in Chemistry, Chemical Engineering, Nuclear Engineering, Radiopharmaceuticals, or a closely related field.
• Minimum of 10 years of hands-on experience in the radiopharmaceutical sector, specializing in manufacturing and process development.
• Proven track record in developing and managing intricate technologies, preferably in the domain of radioligand therapy.
• Familiarity with pertinent regulations (FDA, EMA), standards, and guidelines, emphasizing quality, safety, and environmental impact considerations.
• Comprehensive understanding of regulatory requirements related to drug development, with a keen awareness of current US and EU regulations for therapeutic products.
• Must possess profound technical expertise and adept problem-solving skills in nuclear physics, materials science, and radiopharmaceuticals, coupled with the ability to think strategically and communicate seamlessly with all stakeholders.
• Experience with MS Office Suite required.

Knowledge / Skill / Ability

• Exceptional organizational and project management proficiency, which highlight the capability to prioritize and handle multiple tasks concurrently.
• Ability to convey complex ideas in a simple manner to management and customers.
• Ability to understand and communicate scientific or technical information.
• Ability to work across multi-disciplinary groups and lead decision-making discussions.
• Excellent interpersonal, negotiation, communication, and collaborative skills.
• Demonstrated record of high productivity and results.
• Ability to travel up to 25%.

Work Environment 

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• May be required to sit or stand for long periods of 8 hours a day while performing duties.
• Willingness to complete safety training within allotted time limits, and work in a team-based environment.