POSITION SUMMARY:

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.

PRINCIPAL RESPONSIBILITIES:

Leadership:

• 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.

Continuous Improvement:

• 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.

Process Optimization:

• 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.

Regulatory & Compliance Support:

• Ensure process improvements align with cGMP, FDA, EMA, and nuclear regulatory requirements.

• Work closely with QA and RA to integrate compliance into operational practices.

Team Leadership & Development:

• Build and mentor a high-performing OpEx team.

• Train and engage site employees at all levels in Lean methodologies and tools.

QUALIFICATIONS & REQUIREMENTS:

• Bachelor's degree in a scientific, engineering, or business field required. A Master’s degree (e.g., MBA or MS in Engineering) is preferred.

• 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.

• Pharmaceutical, biotechnology with specific contract manufacturing or radiopharmaceuticals, or advanced manufacturing demonstrated project management work experience preferred.

• A deep understanding of the unique challenges and regulatory requirements of the radiopharmaceutical industry, including handling of radioactive materials and cGMP (current Good Manufacturing Practice).

• 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.

• Travel up to 30% expected as position / company grows

THE FINE PRINT:

The salary range for this position in Minnesota is $110,000 to $140,000 annual. 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.