Manager, Operational Excellence

Nucleus RadioPharma • Ambler, PA

80d • $110,000 - $140,000

About The Position

The Manager, Operational Excellence will lead and implement a culture of continuous improvement across manufacturing, quality, and support functions within a radiopharmaceutical CDMO environment. This role is responsible for developing and executing strategies that enhance productivity, reduce cost, ensure regulatory compliance, and improve client satisfaction. The Manager, Operational Excellence has expertise in Lean, Six Sigma, and operational strategy-along with a strong understanding of the unique challenges in radiopharmaceutical manufacturing and handling.

Requirements

• Bachelor's degree in a scientific, engineering, or business field required.
• 5+ years in operations management, continuous improvement, or a similar role within a highly regulated industry, with a strong preference for radiopharmaceuticals, pharmaceuticals, or biotechnology, required.
• Lean Six Sigma Black Belt certification is highly desirable.
• Project Management Professional (PMP) certification is also a plus.
• Ability to analyze complex data and identify root causes of problems.
• Proven ability to lead and motivate teams, influence stakeholders, and drive change.
• Excellent verbal and written communication skills to effectively present strategies and results to all levels of the organization.
• Deep understanding of manufacturing processes, quality systems, and regulatory requirements specific to the radiopharmaceutical industry.
• Demonstrated project management work experience in pharmaceutical, biotechnology with specific contract manufacturing or radiopharmaceuticals, or advanced manufacturing preferred.
• A deep understanding of the unique challenges and regulatory requirements of the radiopharmaceutical industry, including handling of radioactive materials and cGMP.
• Demonstrated success in building and leading enterprise-level BPM and PMO functions.
• Exceptional leadership, influencing, and change management skills.
• Ability to thrive in a fast-paced, client-focused, and highly regulated environment.
• Demonstrated problem solving skills, communication skills, time management, collaboration, team building and organizational skills.
• Proficient with project management methodologies and tools (Microsoft Project).
• Familiarity with regulatory requirements (e.g. OSHA, EPA, NRC) and quality standards (e.g., GMP, FDA, EMA).
• Ability to run effective project meetings, workshops and conferences.
• Highly organized with strong attention to detail and commitment to high quality work.

Responsibilities

• Drive the Operational Excellence (OpEx) strategy aligned with corporate goals.
• Lead cross-functional initiatives that enhance efficiency, compliance, and quality.
• Champion a data-driven, continuous improvement culture throughout the organization.
• Implement and manage Lean, Six Sigma, and Kaizen initiatives.
• Identify operational inefficiencies and lead structured problem-solving efforts.
• Design and implement performance KPIs and dashboards across departments.
• Optimize radiopharmaceutical production processes for yield, throughput, and cost.
• Collaborate with R&D, Quality, and Engineering to ensure seamless tech transfer and scale-up.
• Support digital transformation initiatives in operations and manufacturing systems.
• Ensure process improvements align with cGMP, FDA, EMA, and nuclear regulatory requirements.
• Work closely with QA and RA to integrate compliance into operational practices.
• Build and mentor a high-performing OpEx team.
• Train and engage site employees at all levels in Lean methodologies and tools.

Benefits

• Medical, dental, and vision insurance.
• Health Savings Account or Flexible Spending Account options.
• 401k retirement account access with employer matching.
• Paid sick leave and/or other paid time off in compliance with applicable law.
• Relocation available to qualified team members.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 1-10 employees