Director, Manufacturing

Nucleus RadioPharma • Rochester, MN

33d

About The Position

The Director, Manufacturing will oversee production activities, facility readiness, and batch execution across aseptic, hot-cell, and cleanroom environments, while supporting the execution of Tech Transfers. This includes maintaining validated processes and equipment, ensuring adherence to Standard Operating Procedures (SOPs), and driving a culture of quality, safety, and continuous improvement. The Director, Manufacturing will serve as a key member of the site leadership team, partnering closely with Quality Assurance, Quality Control, Engineering, MSAT, Supply Chain, EHS, Process Excellence, PMO, and client technical teams to ensure the reliable delivery of radiopharmaceutical products and services. The role will foster a strong and proactive partnership with the Technology Transfer and MSAT organizations to ensure seamless execution of process implementation, scale-up, validation, and commercial readiness. This collaboration will be central to establishing operational robustness, enabling efficient tech transfers, and supporting the successful advancement of both clinical and commercial manufacturing programs. Together, Operations and MSAT will maintain a continuous feedback loop to capture process learnings, drive innovation, and implement data-driven improvements that strengthen product quality, efficiency, and overall site performance. The Director, Manufacturing will also be responsible for building, developing, and leading a high-performing operations organization, with a focus on hiring top talent, strengthening technical and leadership capability, and fostering an environment of accountability, engagement, and continuous learning. This role champions a culture where collaboration, transparency, and performance excellence are core to how teams operate and deliver results. In addition to operational oversight, this role will contribute to long-term site strategy, capital planning, and continuous improvement initiatives that strengthen reliability, compliance, and productivity. The Director, Manufacturing will ensure that site operations are consistently inspection-ready, aligned with corporate objectives, and positioned for future growth.

Requirements

• Bachelor's degree in chemistry, engineering, biology, pharmacy, or related science required.
• 10+ years of relevant experience which should include pharmaceutical management experience required.
• 8+ years of managerial experience with direct oversight of a team required.
• Knowledge of and ability to apply CGMP requirements to sterile injectable drug product development and manufacturing, for example: US FDA 21CFR part 211, EU GMP Annex 1 required.
• Experience working in the radiopharmaceutical industry required.
• Demonstrated problem-solving skills and ability.
• Must be adaptable to a changing environment and changing responsibilities.
• Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations
• Ability to work as a team member, socialize ideas and build successful working relationships
• Demonstrates a high commitment to quality.
• Ability to work independently with minimal direction, and drive deliverable through to completion by deadlines provided
• Highly organized with strong attention to detail and commitment to high quality work
• Proficient in use of Microsoft suite of products.
• 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.
• Ability to work extended hours, shift and weekends as needed.
• Ability to travel up to 10% expected as organization grows.

Responsibilities

• Provide strategic and hands-on leadership of daily radiopharmaceutical manufacturing operations within cGMP facilities, ensuring consistent compliance with 21 CFR Part 211, radiation safety regulations, and site procedures.
• Oversee all aspects of production including aseptic filling, formulation, dispensing, labeling, packaging, and material flow across classified cleanroom and hot-cell environments.
• Ensure operational readiness of personnel, processes, and equipment to meet client, regulatory, and internal quality expectations.
• Maintain strict adherence to cGMP, ALCOA+ data integrity principles, and radiation safety requirements.
• Partner closely with Quality Assurance to ensure deviation management, CAPA implementation, and batch record accuracy.
• Support internal and client audits, regulatory inspections (e.g., FDA, NRC, EMA), and client qualification activities.
• Develop, implement, and track key performance indicators (KPIs) for safety, quality, delivery, and cost. Implements root cause analysis and partners with Process Excellence team to learn from challenges and mitigate mistakes.
• Drive continuous improvement initiatives using lean manufacturing and risk-based approaches to optimize processes, reduce downtime, and increase throughput.
• Lead investigations and root cause analyses, ensuring sustainable preventive actions are implemented.
• Collaborate with MSAT, Engineering, and Quality functions to ensure successful technology transfers and process validation for new radiopharmaceutical products.
• Active participate in client project meetings, ensuring alignment on timelines, scope, and deliverables.
• Support process scale-up and lifecycle management activities consistent with regulatory and client expectations.
• Lead, coach, and develop the manufacturing team to build technical depth, cGMP discipline, cross-functional collaboration, and a high performing-engaged team.
• Foster a culture of safety, accountability, and operational excellence throughout all manufacturing activities.
• Ensure ongoing training, qualification, and performance evaluation of staff in accordance with cGMP and radiation safety standards.
• Partner with Engineering and EHS to ensure facility, utilities, and equipment are maintained in validated and compliant state.
• Oversee equipment calibration, preventive maintenance, and readiness for production and validation campaigns.
• Ensure robust change control and documentation practices are followed for all operational assets.
• Monitors emerging trends in radiopharmaceutical manufacturing technologies, including hot cells, sterility isolators, and automated vial filling systems, to ensure cutting-edge operational capabilities.
• Recruit, interview, hire, and train management and support staff within the Operations department, ensuring appropriate technical capability and leadership succession planning.
• Performs other duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 1-10 employees