K360 Materials Management Technical Services Rep – CT Pilot Plant, BRD Bioprocess Operations

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$76,500 - $112,200

Job Description

The Clinical Trial (CT) manufacturing organization is responsible for the production of drug substance, supporting the BRD organization and their objectives. The facility is focused on new protein therapeutics to market by producing bulk drug substance (API) for clinical trials, along with the associated technical data and documentation to support GMP activities. The plant is located within Building 360 (K360) in Indianapolis, IN at the Lilly Technology Center North campus.

The K360 Materials Management Technical Services Rep is responsible for the direction & oversight of consumable planning and buying for K360 along with being a liaison for raw materials/makeup/dispensing. The role is responsible for all aspects of inventory management and risk management strategies for GMP consumables in K360.  The individual in this role will also partner with Lilly external manufacturing and commercial manufacturing sites, representing K360 on global consumable material strategy projects.  The role is responsible for working closely with the raw material coordinator and makeup/dispensing supervisor to implement process improvements focused on safety and throughput.

Key Objectives and Deliverables: 

• Serve as liaison between the Materials Management Team and K360 Operations.
• Work with the Materials Management Team to:
  • Assess materials & supplier risk
  • Assess & address impact of supplier changes
  • Develop robust control strategies to manage supplier/material risk.
• Oversee the K360 consumable management process
  • Create tools to simplify and streamline consumable process from initiation through use.
  • Own and manage the consumable list, which entails qualifying new consumables, ensuring specifications, supplier changes and supplier information is maintained and in a constant state of compliance.
  • Develop relationships through communication with vendors to ensure line delays and product changes have limited impact on K360
  • Consult and Interact with external manufacturing contacts to help streamline their ability to have appropriate consumables on time.
  • Partner with multiple Lilly manufacturing sites to learn and streamline the consumable pipeline
  • Oversight for ULS management of dock and consumable warehouse.
  • Prepare, review, approve and provide technical support for preparation of relevant technical documents such as change controls, deviation investigations and summary reports, procedures, technical reports, etc.
• Lead and/or coordinate materials investigations and changes.
• Participates in departmental site self-assessments and relevant audits representing dock area, consumable process, and receipt and verification.
• Coach and mentor staff to ensure understanding of the raw materials and consumable process.
• Collaborate with site and global resources to support materials

Basic Requirements:

• Exceptional organizational skills with attention to detail
• Ability to work independently and handle multiple projects
• Ability to communicate and work effectively with Operations, Tech Services, Engineering and Quality groups.
• Ensure a safe working environment by following safety rules and helping implement/improve the safety culture
• Demonstrate engagement and employ a quality mindset in all endeavours by proactively identifying quality issues and communicate appropriately.
• Ability to respond to changing priorities and short lead times
• Excellent verbal and written communications skills with the ability to interact well in a team environment

Additional Preferences:

• Demonstrated technical capability with high productivity
• Proven track record of curiosity with learning agility
• Self-starter with high initiative and data-driven approach to problem-solving
• Demonstrated ability to participate in and facilitate decision-making
• Experience with the application of GMPs in a clinical tr