Director – Project Management, Operations, Quality and Process Improvement Specialist at Eli Lilly and Company

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.

Veterinary Resources {ATPLV} Organization enables the Discovery and Clinical Development of Drug candidates by investigating and establishing Drug Safety and Clinical Developability. As part of the ATPLV Organization, LEM is responsible for the development and oversight of immunogenicity and biomarker assays (both internally and externally driven) in support of clinical studies. The LEM specialist, in collaboration with scientists across ATPLV, will provide project management and operational leadership in areas including, but not limited to; fiscal, logistical, quality, and select scientific aspects of the operations. The successful candidate will proactively enable the planning, preparation, analysis, tracking, and reporting of clinical trial activities / samples / data. When necessary, and as directed, the specialist will also provide consultative support to leadership, scientists, Product Team, Clinical Lab Services (CLS) associates, and Third-Party Organizations (TPO)s. Finally, the successful candidate will be expected to aid in the identification of, and drive process improvement / organizational efficiency, through various methods including adoption of automation and new tools / technologies to replace existing manual processes.

Are you a project manager with strong operational leadership experience? Apply today to join Team Lilly!

• Focus on process delivery, automation, and improvement, initially targeting LEM.
• Improve insourcing/outsourcing processes for consistency and efficiency.
• Apply business tools to streamline processes, reduce turnaround times, and cut costs.
• Lead continuous process improvements using tools, apps, and automation.
• Handle tools and resources to scale support appropriately.
• Collaborate with scientists to train new employees on quality expectations and documentation.
• Ensure completion of QA-audit corrective actions.

• Accountable for data/results from third-party organizations (TPOs).
• Handle critical reagents and lab supplies.
• Stay updated on TPO technologies and performance to mitigate risk and optimize study support.
• Lead troubleshooting of data integrity/operational issues with TPOs.
• Ensure regulatory compliance through updated procedures based on audits and regulations.

Master’s degree (or Bachelor’s with additional experience in science) with at least 10 years of experience.

• Experience in a regulated (e.g. GLP, GCP, GMP, etc.) environment, specifically related to a bioanalytical (immunogenicity, biomarkers and/or PK) environment, with a focus on large molecules and newer modalities - ELISA and Mass Spectrometry applications.
• Experience in developing, improving and implementing a quality system for a GLCP analytical lab, including the processes from sample collection instructions/shipping/receipt through data reporting, as well as ancillary infrastructure processes.
• End to end experience in streamlining analytical processes and documentation.
• Experience in tactically implementing an outsourcing strategy, from developing new successful TPO partnerships, governance and daily oversight expertise, to implementing new processes/tools.
• Experience in Regulatory Audit interactions.
• Strong background in budget tracking and forecasting.
• Proven project management, operations, and outsourcing expertise.
• Must be able to lead multiple projects and meet timelines while maintaining compliance.
• Experience in demonstrating process effectiveness/success as well as evaluating when improvements are needed. Experience of developing and implementing process improvements using automation.

Travel <20%

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