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.

Overview:

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.

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

In the Project Delivery Phase and Startup Phase of the project (2025 to 2028), the FLT roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations and build the site culture. This will require significant collaboration, creativity and resilience as the Lilly Medicine Foundry goes from design, to start-up, and to steady-state operations.

The Senior Director, Analytical Operations position seeks a collaborative, inclusive, and energetic leader who will define and lead the organization that will support the Quality Control and Analytical laboratories in support of the site and Lilly’s growing pipeline. The Lilly Medicine Foundry, a state-of-the-art facility, will utilize the latest in automation to further the analytical capabilities including on-line in-process control testing through material release and ongoing process monitoring at the site. The Analytical group will consist of high-level scientists focused on the implementation/transfer of new modalities and the implementation of analytical process improvements. This position involves working cross-functionally within the site and across the network to develop the strategic functional capabilities and will ensure appropriate capacity, capabilities and business processes are developed, implemented and sustained to deliver the site plan. This position will be key to ensuring a strong safety culture and establishing a safety, quality and continuous improvement focused mindset within the organization.

This position will report to the Foundry Site Head and is a member of the Foundry Site Lead Team (FLT). The FLT has collective responsibility to develop and implement the strategic direction, organizational capability and management of the site. Primarily, the members of the team drive the site toward achieving long term business objectives; they continuously develop the business and the organization for the future bearing in mind corporate and LRL objectives and the continuously changing external environment; and they manage issues that span multiple teams in the organization and extend into the broader corporate and external context.

*NOTE: final location for this role will be Lebanon, IN site but flexibility to work from Indianapolis will be required throughout 2025 and 2026.  

Key Responsibilities:

Strategic Management

Define strategic direction for the site, including near-term, medium-term, and long-term planning and monitoring of business plan execution,

Partner with Process Research and Development (PR&D) leadership to ensure the Analytical Operations group and broader Foundry operating system/culture reflects the speed, innovation, flexibility and reliability needed to meet PR&D and partnering organizations’ needs.

Plan and manage business operational expense, capital and headcount targets. Work effectively with Process Development Project Managers to maximize the throughput and utilization of the facility as well as maintain the schedule.

Review site and area performance periodically with respect to these plans and take corrective actions as appropriate.

Business Management

Provides leadership, direction and governance for Analytical Operations within the Foundry.

Understands regulatory and legal environment and develops appropriate strategies for meeting regulatory agency requirements as pertains to analytical method validation and testing.

Drives continuous improvement of systems within the Analytical organization.

Exhibit critical business decision-making bringing about successful results.

Communicate to and strive for integration of support groups outside plant.

Establish lean practices and a continuous improvement mindset throughout Analytical Operations and the direct supporting organizations.

Coordinate laboratory related business planning and budget management.

Ensure safe work environment that aligns with regulations.

Serve as a conduit for corporate communications as needed.

Personnel Management

Attract, hire and onboard top talent to the Foundry team establishing the right attitude, curiosity and learning agility to deliver on the Foundry mission.

Provide administrative support for direct reports in the Analytical Operations group.

Work with individual reports to develop and maintain their training, performance management plans and career plans, providing consensus feedback and manage/assign workloads.

Coach and mentor others in all aspects of leadership, business and technical insight.

Develop the future management and technical leadership for the site and for potential assignments in PR&D and manufacturing.

Technical Excellence / Compliance Oversight

Build the organization with the necessary capability, capacity and culture to operate the Foundry to the highest standards of safety, quality, and operational excellence.

Be responsible for delivering on the diverse and evolving development portfolio, meeting speed and reliability expectations while accommodating flexibility to meet changing priorities in the clinical space. In parallel with delivering the portfolio, continue to pursue improvement opportunities related to both strategic and essential capabilities.

Implement the lab of the future vision including integrated digital, paperless processes.

Ensures advancement in Analytical Technology at the site.

Support and provide governance for the site in addressing issues related to maintaining Analytical Operations in a compliant state.

Responsible for review and approval of specific quality documents consistent with procedure requirements; including but not limited to, validation packages, suspect result reviews, deviations and change controls as appropriate.

Responsible, in conjunction with QA, for escalation of critical laboratory related issues as appropriate to off-site Quality Management consistent with site procedure on Notification to Management.

Coordinate and lead all regulatory and internal inspections.

Collaborate on the local area lead teams and Quality Lead Team.

Basic Requirements:

Ph.D. in analytical, biophysical, biochemistry, molecular/cell biology, or related field with relevant pharmaceutical experience; or B.S. or M.S. with 15+ years of experience commensurate with a Ph.D. chemist/biochemist.

Experience in a leadership role managing Analytical operations, new product introduction, or relevant process development support experience within the pharmaceutical industry.

On-site presence required.

Additional Skills/Preferences:

Fundamental knowledge of cGMP/GLP compliance requirements.

Knowledge in quality and compliance requirements for analytical laboratories and regulatory requirements.

Creativity, imagination, and ability to transform ideas into improved products and processes.

Strong problem solving and decision-making skills.

Ability to prioritize multiple activities, manage ambiguity, and to drive and accept change.

Effective oral and written communication skills, self-management, knowledge and experience in project management, and demonstrated ability for development workplans and communication of workplans.

Significant knowledge to efficiently and productively collaborate and influence in an interdisciplinary team environment (e.g. regulatory, quality, production, process, engineering).

Demonstrated success in persuasion, influence, and negotiation skills. Influence others to promote a positive work environment.

Demonstrated initiative and risk-taking.

Should have experience developing and managing extremely talented, engaged and high performing teams with a focus on building strong team cultures to ensure a safe, innovative and successful work environment.

Other Information:

Ability to travel (approximately 10%)

*NOTE: final location for this role will be Lebanon, IN site but flexibility to work from Indianapolis will be required throughout 2025 and 2026.  

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.

#WeAreLilly

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

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.

#WeAreLilly