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.

BASIC QUALIFICATIONS

• Education:
• Bachelor`s Degree or equivalent work experience in Pharmacy, Chemistry, Engineering, or similarly related fields.
• Experience:
• Minimum of 3 years’ experience in pharmaceutical manufacturing and/or in Operations.
• Skills:
• Ability to represent Eli Lilly’s mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs.
• A thorough understanding of cGMPs and drug product manufacturing.
• Strong communication (written and oral) skills, teamwork, and influence.
• Demonstrated Leadership
• Proven ability to organize and prioritize multiple tasks using a lean Six-Sigma approach
• Capability to work in a virtual and complex environment.
• Appreciation for cultural diversity.
• Willingness to travel.
• Language spoken - fluent English.

ADDITIONAL SKILLS/PREFERENCES

• Knowledge and ability to apply basic statistical tools.
• Basic knowledge on common Lean Six-Sigma Programs
• Experience in Continuous Improvement and Operational Excellence processes
• Prior experience supporting Parenteral manufacturing.

RESPONSIBILITIES

This role is responsible for all activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards.
This role is a member of the joint process team (JPT) and has direct responsibility for oversight of the day-to-day operations at the CM.

THIS ROLE WILL BE A PERSON IN PLANT AT A CM BASED IN LATINA (ITALY) PARENTERAL MANUFACTURING SITE.

Key Objectives/Deliverables:

• Define operational excellence roadmap and support CM in the implementation to improve safety, quality and productivity
• Invest time on the shop floor to ensure practices are matching local procedure. Identify and promote operational best practices on the floor and set Lilly expectations.
• Establish and promote human error prevention program, tracking metrics and CM overall performance
• Transfer operational knowledge to the CM to minimize recurrent deviations ensuring flawless execution on the floor
• Support on-going CM Operations by providing operational oversight at the Joint process Team as Primary Loop support
• The Operations PiP. as a Person in Plant and as a member of the Joint Process Team should be the facilitator of the communication between the CM and the JPT, including:
• become the primary contact person for the JPT, supporting the JPT Leader for escalation and issue management
• Spend time on the floor to understand unit operation and the CM technology and monitoring line performance.
• Spend time during Lilly product is running in the manufacturing/assembling/packaging lines.
• Having a holistic understanding/knowledge of the product/process, and its associated equipment, facilities, computer system and operations.
• Defining, understanding, and owning the process control strategy including the key process parameters, critical quality attributes.
• Understanding product history and potential failure modes of the process.
• Contribute to identify and implement Continuous Improvement and Operational Excellence projects at the CM
• Support JPT members to monitor the Technical Agenda identified at CM
• Manage conflict and problem resolution.
• Assist to the CMs on the preparation of any audit from Lilly (GQAAC) or any external agency that impact Lilly products.
• Translating process requirement and education to the Joint Process team members.
• The Operations PiP as a Person in Plant should provide support to the management of daily operations including:
• Support JPT members on deviations and complaints management facilitating the interface between Lilly and the CM
• Assist to JPT members supporting the CM on periodic documents preparations and presentation delivery
• Support the root cause analysis process in case of deviations or complaints collaborating with CM SME (shopfloor presence)
• Ensuring planned changes and deviations are managed appropriately. Respond in a timely manner and accurately to requests for information.
• Proving trouble shooting support and maintaining awareness of issues & progress their resolution ensuring that JPT members and senior management are notified through approved escalation procedures.