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

$63,000 - $140,800

The Laboratory for Experimental Medicine (LEM) group oversees internally supported and outsourced immunogenicity and related biomarker assays in support of clinical studies.  LEM is part of the broader ADME, Toxicology and PK/PD division within Lilly.  The Project Manager, in collaboration with scientists, will provide support for ongoing projects to ensure on-time data deliverables. The individual will perform a myriad of project management and operational support activities to proactively enable the planning, preparation, analysis and reporting of clinical samples and data.  This includes fiscal, logistical, quality and select scientific aspects of the operations.  When necessary and as directed, the Project Manager will provide consultative support to their leadership, scientists, Product Team, Clinical Lab Services (CLS) associates, and Third-Party Organizations (TPO)s. The individual will drive process improvements by automating existing manual processes and leading in the development of new tools. 

Do you have a scientific background in a regulated environment and strong project management skills? Apply today to join the Lilly Team!

Responsibilities:

1) Use project management skills and experience to impact process delivery where applicable within LEM. 

2) Drive process improvements for consistent and efficient insourcing and outsourcing processes.

3) Lead in developing new tools/automation to develop improved communication channels.

4) Work with the scientists to manage Immunogenicity and Biomarker assay validation and sample analysis activities.  Responsibilities may include:

Preparing the lab with contracts, reagents, requirements, and timelines for assay transfer, validation and sample analysis activities. Accountable for all LEM Immunogenicity and Biomarker data and report deliverables.Proactively manage critical reagents and applicable documentation, as well as any critical supplies (e.g. plates, etc.).Coordinate assay monitoring activities, reagent bridging, trouble-shooting data integrity and/or operational issues with the lab and LEM scientists,Accountable for understanding and applying new processes to improve data management,Manage Quality Assurance (QA)-audit finding corrective actions (from on-site Lilly QA audits at internal and external labs), regulatory audit requests, issue escalationCoordinate with scientific and operational personnel to ensure business continuity, solution implementation, timelines, and clarity in expectationsManage Governance meetings and oversight trips with the external labs.  Drive action plans to completion between Lilly and the external labs.  Communicate key deliverables/updates from the Clinical Lab Sciences group to the appropriate LEM and third-party representatives.

Basic Requirements:

Bachelor's or Master’s degree in science3+ years of experience

Additional Skills/Preferences:

Proven organizational skills.  Works well in challenging environments.Excellent oral and written communication skills.Ability to influence and mentor other individuals. Strong interpersonal skills, including coaching others within or outside of their direct supervision/group. Able to gain alignment when different views are available.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 determining when improvements are needed.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 applications.Project Management Software experienceExperience in processes from sample collection instructions/shipping/receipt through data reporting, as well as ancillary infrastructure processes.Experience in tactically implementing an outsourcing strategy, from developing new successful TPO party collaborations, governance and daily oversight expertise, to implementing new processes/tools. Experience in Regulatory Audit interactionsStrong background in budget tracking and forecasting

Additional Information:

• Travel 0-5%
• On-site Position (at Lilly Corporate Center, Indianapolis)
 

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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