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.

The Laboratory for Experimental Medicine (LEM) supports immunogenicity and biomarker assays for clinical studies, with a focus on large molecule therapeutics. LEM is part of the broader ADME, Toxicology and PK/PD division within Lilly. The individual will perform a myriad of project management and operational support to proactively enable the planning, preparation, analysis and reporting of clinical samples. This includes fiscal, logistical, quality and select scientific aspects of the operations. When necessary and as directed, the specialist 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.

Key Responsibilities:

Use the skills and experience to impact process delivery / automation / improvement where applicable across the division, initially focusing on the LEM. Drive process improvements for consistent and efficient insourcing and outsourcing processes across the division.
Partner in utilizing novel business tools to streamline processes decrease turnaround time and decrease direct/indirect expenses on numerous deliverables. Lead constant process improvements through the use of tools/apps/automation in the appropriate validated state.
Drive tool and resource management to scale support appropriately.
Work with the scientists to provide operational oversight activities in a regulated environment.
Responsibilities may include: i) accountable for data and summary results provided to and received from TPOs, ii) proactively managing critical reagents and laboratory supplies, iii) remaining current on new TPO technologies/capabilities as well as ongoing performance to manage enterprise risk and providing recommendations for optimal study support, iv) lead the group in trouble-shooting data integrity or operational issues with the TPO, v) accountable for identifying process improvements, vi) understanding and applying new processes to improve data management from TPOs, vii) maintain current regulatory compliance by leading the revision of current procedures with new pertinent regulatory expectations identified through discussions with TPO partners, documented audit findings, and information generated from scientific and/or regulatory conferences, viii) In collaboration with the applicable scientists, successfully train new employees on quality expectations, tools and sponsor oversight documentation skills, ix) Serve as the accountable business partner to ensure Quality Assurance (QA)-audit finding corrective actions (from on-site Lilly QA audits and TPOs) are completed.

Basic Requirements

Master’s degree in science with at least 10 years of experience, or bachelor’s with additional experience.
Proven leadership and 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, outsourcing and/or six sigma 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 of developing and implementing process improvements utilizing automation.

Additional Preferences

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.
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.
Experience collaborating/leading automation enhancements, including the identification of improvements and tool development.

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 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. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$111,000 - $162,800

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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Associate Director - LEM Operations