Director, Radiopharmaceutical Development
Nucleus RadioPharma
PRINCIPAL RESPONSIBILITIES:
• Lead RLT Product Development: Oversee the technical execution of RLT product development at the Rochester site, ensuring robust and scalable processes for client deliverables.
• Innovate Synthesis and Formulation: Develop and optimize small-scale synthetic processes, methods, and formulations for RLT products, including labeling of small molecules, peptides, and antibodies with therapeutic alpha-emitting (e.g., 225Ac, 212Pb, 211At) and beta-emitting (e.g., 177Lu, 161Tb, 67Cu) radioisotopes.
• CMC Data Package Delivery: Direct the development team in generating comprehensive CMC data packages to meet client and regulatory requirements, ensuring seamless integration into clinical and commercial pipelines.
• Strategic Technical Development: Build and enhance technical expertise to address future radiopharmaceutical needs, including novel isotopes, targeting agents, and advanced delivery systems.
• Team Leadership and Mentorship: Supervise, train, and mentor junior staff and direct reports, fostering a collaborative and innovative team environment to achieve project milestones.
• Project Management Collaboration: Partner with leadership and project management teams to develop project plans, timelines, budgets, and client reports, ensuring alignment with organizational goals.
• Quality and Compliance Support: Assist in investigating and resolving product deviations in the production facility, ensuring adherence to Good Manufacturing Practices (GMP) and regulatory standards.
• Cross-Functional Engagement: Collaborate with internal and external stakeholders, including R&D, manufacturing, and quality assurance teams, to drive project success and innovation.
• Continuous Improvement: Identify opportunities to enhance processes, implement cutting-edge technologies, and improve operational efficiencies in radiopharmaceutical development.
• Additional Duties: Perform other responsibilities as assigned to support the mission of Nucleus RadioPharma.
QUALIFICATIONS & REQUIREMENTS:
• Ph.D. in Radiochemistry, Chemistry, or other related science required;
• Minimum 5 years of relevant experience which should include extensive hands-on work labeling small molecules, peptides, and/or antibodies with a variety of therapeutic alpha- and beta-emitting radioisotopes required;
• Prior experience with direct reports required;
• Experience in preparing CMC documentation for regulatory submissions (e.g., IND, NDA).
• Familiarity with GMP environments and radiopharmaceutical manufacturing processes.
• Proven track record of successful client engagements and project delivery in a fast-paced, innovative setting.
• Technical Proficiency: Advanced ability to design, analyze, and interpret complex data sets using logical, statistical, and mathematical methodologies.
• Problem-Solving: Demonstrated ability to proactively identify issues, prioritize tasks, and implement effective solutions in a dynamic environment.
• Leadership and Collaboration: Exceptional interpersonal and communication skills, with a proven ability to lead teams, foster collaboration, and build strong working relationships.
• Independent Work Ethic: Capacity to work autonomously, manage multiple priorities, and deliver high-quality results within tight deadlines.
• Attention to Detail: Highly organized with a commitment to precision, quality, and compliance in all aspects of work.
• Adaptability: Willingness to work extended hours or weekends as needed to meet project demands.
• Innovation Mindset: Passion for exploring novel technologies and methodologies to advance radiopharmaceutical development.
THE FINE PRINT:
The salary range for this position is $150,000 - $200,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location.
Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members.
This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.
Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.