Scientist, TS/MS - Device Assembly

About the role

Lilly is designing and building a new state-of-the-art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This role supports the implementation of technical objectives through execution activities and partnerships with the device assembly operations and engineering teams.

Responsibilities

• Serve as TS/MS representative for the Device Assembly Process Team.
• Support non-routine investigations, including consultation on quality and stability issues.
• Represent Concord TSMS team for internal and external communications.
• Lead risk management activities related to product/process.
• Prepare and review relevant technical documents, such as Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFEMAs, etc.
• Develop, monitor, and react to established metrics to assess process variability and capability.
• Identify and lead technical projects to improve process control and/or productivity.
• Interface with upstream suppliers and global device/drug product networks.
• Drive stability strategy for Concord products.
• Provide audit support as needed.
• Participate in projects to improve process control and/or productivity.

Requirements

• Bachelor's or equivalent degree in Science or Engineering (preferred)
• 2+ years of experience in a manufacturing organization

Qualifications

• Proven ability to work independently or as part of a team to resolve issues.
• Strong attention to detail.
• Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP.
• Knowledge and understanding of manufacturing processes.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills.