Sr. Director- Packaging

Role Summary

The Sr. Director - Packaging provides operational leadership to ensure effective delivery of device packaging. This role supports assets deployed at Lilly RTP, reports to the RTP Site Head, and is a member of the Site Lead Team. It collaborates with the RTP Lead Team to accelerate ramp-up and stabilization of deployed assets and may have back-up responsibilities for device assembly operations. Location: Lilly Research Triangle Park site.

Responsibilities

• Provide Health, Safety and Environmental (HSE) and Quality leadership for the DAP Flow team.
• Support Site Leadership to build a diverse and capable site organization based on engineering first principles and operational excellence. Talent management, development, and retention within the RTP organization (and beyond).
• Represent operational capabilities beyond the Lilly RTP site (e.g., other Lilly sites and global functional groups).
• Partner with Technical Services, Quality and Engineering leadership to deliver functionally strong and operationally centered results.
• Develop and refine local processes and procedures for the operational function.
• Ensure practice matches procedure.
• Champion continuous improvement.
• Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Participate in the development and implementation of strategies associated with Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
• This role has direct interaction with Regulatory Agencies during site inspections.
• Understand and influence the manufacturing control strategy for device packaging.

Qualifications

• Required: At least 10 years engineering experience in a manufacturing site
• Required: At least 5 years previous management or leadership experience including leading or working effectively with a cross-functional group
• Required: Front line experience in device assembly and/or packaging operations
• Preferred: Excellent interpersonal, written and oral communication skills
• Preferred: Strong technical aptitude and ability to train and mentor others
• Preferred: Ability to handle multiple competing priorities
• Preferred: Solid understanding of basic requirements of regulatory agencies
• Preferred: Previous facility or area startup experience
• Preferred: Previous experience in operations and engineering
• Preferred: Previous experience with highly automated equipment
• Preferred: Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
• Preferred: Previous equipment qualification and process validation experience
• Preferred: Previous experience with Manufacturing Execution Systems and electronic batch release
• Preferred: Previous experience with Automated Storage and Retrieval Systems (ASRS) or AGVs
• Preferred: Previous experience with deviation and change management systems including TrackWise

Skills

• Excellent interpersonal, written and oral communication skills
• Strong technical aptitude and ability to train and mentor others
• Ability to handle multiple competing priorities
• Solid understanding of regulatory agency requirements
• Experience with highly automated equipment
• Experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
• Experience with Manufacturing Execution Systems and electronic batch release
• Experience with Automated Storage and Retrieval Systems (ASRS) or AGVs
• Experience with deviation and change management systems including TrackWise

Education

• Bachelor's degree in engineering

Additional Requirements

• Ability to work 8-hour days – Monday through Friday
• Ability to work overtime as required