Head (Manager) Production Support & CI

Role Summary

Head, Production Support & Continuous Improvement, based in Millburn, NJ. Lead a high-performing Production Support and Continuous Improvement team to elevate on-time, right-first-time manufacturing for Radioligand Therapy. Champion safety, quality, and inclusion; orchestrate cross-functional problem-solving; translate insights into streamlined processes that reduce variability and accelerate delivery. Strengthen inspection readiness and implement lean practices to unlock sustained productivity and improve patient outcomes.

Responsibilities

• Lead the site Production Support team, Project Management, and Operational Excellence initiatives to achieve site goals.
• Oversee project timelines and budgets while ensuring clear communication across internal and external partners. Responsible for Production Support Budget planning, execution and adherence.
• Ensure effective oversight of production-related investigations (deviations, OOS, OOE, OOT, CAPAs, and trending) and Change Control systems. Communicate status and issues clearly, assess associated risks, analyze deviation and event trends, and drive timely resolution through defined action plans.
• Manage timelines and deliverables for technology transfer, process development, and other projects executed at site and CMOs.
• Optimize manufacturing workflows through continuous improvement and corrective action implementation.
• Serve as subject matter expert on product and process knowledge to support Annual Quality Product Reviews and drive innovation.
• Establish and maintain full compliance with cGMPs and Environmental Health and Safety standards.
• Maintain the master manufacturing documents for assigned products (e.g., Master Batch Record, BOM & Recipe, Quality Risk Assessment).
• Prepare for and participate in health authorities’ inspections and internal audits.

Qualifications

• Required: 5+ years of experience in manufacturing, quality, or another technical function within the pharmaceutical industry.
• Required: Proven leadership experience with the ability to guide, develop, and motivate teams.
• Required: Strong communication, analytical, and problem-solving capabilities to support decision-making in a regulated environment.
• Required: Demonstrated experience collaborating effectively across functions and sites to deliver on shared objectives.
• Required: Knowledge of Good Manufacturing Practice requirements and continuous improvement methodologies applied in regulated operations.
• Preferred: Experience in radiopharmaceutical manufacturing or Radioligand Therapy environments.

Education

• Bachelor’s degree in engineering, science, or a related field, or equivalent relevant experience.