Scientist, TS/MS – Device Assembly Full-time

Scientist, Concord Ts/Ms Device Assembly Process Team

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.

The Scientist within the Concord TS/MS Device Assembly process team is a position supporting the implementation of technical objectives through execution activities and partnership with the device assembly operations and engineering teams. This role will initially supplement the delivery of automated device assembly lines and serve as technical resource for internal parties. Upon the start of commercial production, this role's objectives include analyzing equipment/process data, monitoring production metrics, authoring and executing protocols, and serving as a technical asset for process improvement and root cause investigations. This role is expected to interface regularly with the device assembly operations and engineering teams in support of day-to-day operations.

Responsibilities:

• Support the Device Assembly Process Team as TS/MS representative.
• Serve as floor-level support and technical interface for device components, equipment, and operations for the TSMS team.
• Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues.
• Represent Concord TSMS team for internal and external communications on a regular basis
• Lead risk management activities as it pertains to product/process.
• Prepare and Review, as required, relevant technical documents, such as: Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFEMAs, etc.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
• Identify opportunities and lead technical projects to improve process control and/or productivity
• Serve as interface with upstream suppliers and global device/drug product networks • Drive stability strategy for Concord products.
• Provide Audit support as needed.
• Identify opportunities and participate in projects to improve process control and/or productivity.

Basic Requirements:

• Bachelors or equivalent (Science or Engineering related degree preferred)
• 2+ years experience in a manufacturing organization

Additional Preferences:

• Pharmaceutical and/or medical device manufacturing experience
• Root cause investigation experience
• Proven ability to work independently or as part of a team to resolve an issue.
• 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

Additional Information:

• Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and /or off-hour work may be required.
• Position will be based out of Concord, NC site with ability to travel to Indianapolis and other global Lilly sites as required.

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Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 – $171,600.