Associate Director - Manufacturing Operations / Launch Leader

Role Summary

Associate Director - Manufacturing Operations / Launch Leader. Responsible for leading New Product Introduction (NPI) launch activities and manufacturing operations for the Lipid Nanoparticle (LNP) platform at a cutting-edge facility startup in Lebanon, Indiana. Guides cross-functional teams, ensures timely execution of NPI milestones, and integrates LNP capabilities into routine production.

Responsibilities

• Lead cross-functional teams to develop and execute comprehensive launch and NPI plans for genetic medicines, including scope definition, risk management, timeline development, and best practice implementation.
• Partner with BR&D to build process capability and ensure seamless integration of new technologies.
• Serve as user representative, collaborating with engineering project delivery teams to ensure on-time delivery and successful start-up of new assets.
• Align functional teams and leadership around shared goals, representing the Process Team on the Flow Team and setting clear objectives and metrics.
• Coordinate resources, assign tasks, and manage team performance to ensure timely and effective execution of launch and LNP projects.
• Provide 24/7 leadership and support for the Process and Operations Teams, ensuring continuity and responsiveness across shifts.
• Monitor progress against goals, implement corrective actions as needed, and ensure compliance with regulatory and quality standards.
• Oversee day-to-day production activities, ensuring adherence to schedules, quality standards, and yield targets.
• Optimize use of plant, personnel, equipment, and materials, requesting technical support when necessary.
• Drive continuous improvement through RCA, FMEA, and OpEx reviews, owning corrective actions and change initiatives.
• Identify improvement opportunities using the manufacturing management process, set targets, and measure progress.
• Ensure all activities are conducted in compliance with safety, quality, and environmental standards.
• Accountable for managing safety events, attending DRB reviews, and promoting a proactive safety culture across teams.
• Maintain transparent communication with stakeholders, providing regular updates on project status, risks, and mitigation strategies.
• Document all phases of the launch process, capturing key decisions, actions, and lessons learned.
• Set clear expectations, foster understanding of team goals, and hold team members accountable for results.
• Mentor junior staff and promote a culture of innovation, collaboration, and operational excellence.
• Stay current on industry trends, emerging technologies, and evolving regulatory requirements in pharmaceutical NPI.

Qualifications

• Required: Bachelor‚Äôs degree in engineering, science, or a relevant field.
• Required: 5+ years of direct manufacturing leadership experience.
• Preferred: Strong knowledge of project management principles, tools, and techniques.
• Preferred: Excellent interpersonal and communication skills; ability to collaborate at all levels.
• Preferred: Ability to work independently and make sound decisions under pressure.
• Preferred: Demonstrated leadership, results orientation, adaptability, problem-solving skills, and multi-project management.

Skills

• Project management
• Cross-functional collaboration
• Process design and technology integration
• Operational excellence and continuous improvement
• Safety and quality compliance
• Communication and documentation
• Leadership and team development

Education

• Bachelor‚Äôs degree in engineering, science, or a relevant field