Objective
The Senior Director, Radiopharmaceutical Manufacturing is responsible for leading and managing multi-site operations involved in the production of radiopharmaceuticals for both investigational and commercialization of drug products. The role requires expertise in radiochemical synthesis, radiopharmaceutical manufacturing operations, and knowledge of relevant regulations including U.S. FDA 21 CFR 58, laboratory safety, radiation safety, and GMP operations as per regulatory and USP radiopharmaceutical guidance documents.

Essential Functions

• Lead and oversee GMP compliance, operational excellence, and safety initiatives across multiple manufacturing sites specializing in radiopharmaceutical production.
• Accountable for all aspects of budgeting, staffing, including recruitment, talent onboarding, and the strategic development of teams, ensuring alignment with organizational objectives.
• Champion a culture of continuous improvement, promoting operational excellence and adherence to regulatory standards, specifically in the field of radiopharmaceutical manufacturing.
• Spearhead talent development initiatives, recruiting, training, and mentoring staff to achieve professional growth and excellence.
• Utilize technical knowledge and/or coordinate resources to resolve complex manufacturing challenges and recommend ideas to improve the manufacturing processes.
• Drive strategic planning and execution to ensure seamless coordination between multiple manufacturing sites, fostering collaboration and maintaining high standards of performance in radiopharmaceutical manufacturing.
• Direct all activities across facilities responsible for the comprehensive oversight of manufacturing budgets, demonstrating accountability and ensuring strict adherence in the production of radiopharmaceuticals, encompassing both clinical and commercial products.
• Engage with various support functions, including Quality, Engineering, Facilities, CMC Development, Regulatory, Safety, and Logistics, to ensure the fulfillment of the production plan.
• Foster collaboration among manufacturing units, R&D, marketing/sales, and logistics to translate product, process, and service requirements into manufacturing operational plans.
• Proactively promote safety in the workplace including electrical, radiation, fall protection and other workplace hazards.
• Create, communicate and deploy effective growth strategies, technology, organizational development and SOPs through operational excellence.
• Develop short- and long-term strategies and investment proposals which will allow the company to achieve competitive advantages, service leadership, and cost reductions through efficient lean manufacturing methods.
• Provide expertise to executives in the development and implementation of an overall manufacturing and related business strategy, including acquisitions, in order to support business objectives.
• Implement current and new business activities by developing plans and strategies.
• Assist in efforts of overseeing and supporting the expansion of pharmaceutical manufacturing facilities, ensuring successful implementation in both the United States and the rest of the world (ROW).

Qualifications

Education/Experience

• Bachelor's degree in Chemistry, Radiochemistry, Nuclear Pharmacist, Radiation Sciences, Radiology, Nuclear Medicine, Nuclear Physics, Nuclear Engineering, Biomedical Engineering, or a related field.
• 10 years of experience in clinical radiopharmaceutical production.
• Must possess strong technical experience, a comprehensive understanding of the field, and proficiency in safety, regulatory compliance, and documentation.
• Experience with MS Office Suite required.

Knowledge / Skill / Ability

• Familiarity with GMP Manufacturing: Knowledge of working in a GMP manufacturing environment and familiarity with FDA regulations and cGMP guidelines.
• Alpha Emitters: Desired experience with the use of alpha emitters or other high energy isotopes in the specific application.
• Laboratory Procedures and Radiochemistry Techniques: Proficiency in laboratory procedures, including separation techniques (SPE), and radiochemistry techniques.
• Analytical Methods and Equipment: Ability to use and interpret results from analytical equipment such as ICP-MS, ICP-OES, GC, TLC, and radiometric measures.
• Radiation Detector Technologies: Experience with various radiation detector technologies for process monitoring, dose determinations, and radiation safety.
• HPLC and US FDA cGMP: Knowledge and experience in HPLC, radiochemistry synthesis, US FDA cGMP guidelines, radiation safety principles, isotope production, and troubleshooting and maintenance of analytical equipment.
• Knowledge of FDA Regulations: Familiarity with U.S. FDA Code of Federal Regulations Title 21 Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies and other appropriate regulations.
• Exceptional organizational and project management proficiency, showcasing the capability to prioritize and handle multiple tasks concurrently.
• Ability to analyze complex problems and develop effective solutions.
• 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 30%.

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.
• Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift up to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling.
• Must be willing to wear a variety of personal protective equipment.
• 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 timeframes, and work in a team-based environment.