Sr. Operations Associate

Role Summary

The Sr. Operations Associate (OA) will provide leadership within the area’s process team, manage projects and process improvements, and act as a liaison between operations and multiple functional groups to support event management and change controls. The OA will assist the production team on a day-to-day basis, lead investigations, and drive the implementation of actions associated with deviations.

Responsibilities

• Support site leadership to build a capable site organization by delivering area operational procedures, quality processes and controls for the Packaging area.
• Monitor and build a strong safety culture.
• Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations.
• Participate and/or lead cross-functional teams in the development and implementation of strategies for Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE).
• Understand and influence the manufacturing control strategy for their area.
• Trained as a Lead Investigator.
• Develop and monitor metrics for the area.
• Aid in issue resolution, batch/product approvals, and production schedule execution.
• Lead specific activities of the process teams.
• Potential backup of Associate Director/Manager.

Qualifications

• Required: Bachelor’s degree (or equivalent work experience).
• Required: 2 to 5 years of Operations or Manufacturing Support in Pharmaceuticals.
• Required: Responsible for maintaining a safe work environment, working safely, and supporting all HSE goals.
• Required: Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
• Required: Excellent interpersonal, written and oral communication skills.
• Required: Ability to travel up to 10%.
• Preferred: Technical or Science degree.
• Preferred: Previous leadership/supervisory experience.
• Preferred: Career interests in Operations Leadership.
• Preferred: Device Assembly or Packaging experience.

Education

• Bachelors degree (or equivalent work experience in cGMP production).

Additional Requirements

• The position is at the Lilly Research Triangle Park site; during the project phase, a flexible working environment with periodic remote work may be possible based on project phase and site activities.
• Must be flexible to attend meetings or support off-shifts (operations is 24/7).