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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), 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. 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 Analytical Cleaning Advisor role, a technical-track position, seeks a collaborative, inclusive, and energetic individual who will be accountable for providing strategic direction/leadership to ensure that the GMP laboratories within the Lilly Medicine Foundry are equipped to support site cleaning program established for the production of synthetic and biologic drug substances. This role will partner effectively with customer groups/business partners, and the initial focus will be to provide guidance to the testing strategies supporting the kilo lab and production areas and participate in operational readiness to support production beginning in late 2027.

The Advisor may supervise and manage a staff of technical GMP team members and will ensure the quality and reliability of analytical data used for product development, manufacturing, and regulatory submissions. This position will be key to ensuring a strong GMP culture and establishing a safety, quality and continuous improvement focused mindset within the organization.

Responsibilities** **:

+ Drive implementation of GMP analytical strategies to support the cleaning program at the Lilly Medicine Foundry.

+ Have a comprehensive understanding of cleaning verification / validation approaches.

+ Provide support to other Foundry operational readiness workstreams, such as Operations, Quality, and Engineering.

+ Strategic deployment of GMP analytical solutions.

+ Lead in / participate in safety audits, Process Hazard Reviews, On-the-Floor audits, etc., related to the equipment cleaning program.

+ Identify opportunities for process improvement and implementing changes to enhance efficiency and compliance.

+ Implement procedures and controls to ensure the accuracy, reliability, and security of analytical data, including data acquisition, analysis, and reporting.

+ Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.

+ Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.

+ Support Operations Process Team in planning and scheduling daily work during the cleaning process, monitor the cleaning schedule, and facilitate any remediation activities as needed to maintain compliant and on time cleaning processes.

+ Support the Maintenance Planner by scheduling PMs and work orders into the cleaning/turnaround schedule.

+ Welcome varied perspectives to create new solutions.

+ Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP and GMP requirements.

Basic Requirements:

+ Ph.D. in chemistry, biology, or related field with 3+ years relevant pharmaceutical experience; OR B.S. or M.S. with 10+ years of experience.

+ Technical knowledge of cleaning equipment and cleaning regimes.

+ Knowledge of relevant FDA and EU regulations relating to equipment cleaning in clinical trial manufacturing.

+ Fundamental knowledge of cGMP compliance requirements and cGMP experience.

Additional Preferences:

+ Knowledge of Small Molecule and/or peptide/oligonucleotide manufacturing processes and understanding of production schedules.

+ Ability to respond quickly and proactively to changing priorities within a limited timeline.

+ Demonstrated ability to drive and accept change.

+ Good interpersonal skills and a sustained tendency for collaboration.

+ Demonstrated success in persuasion, influence, and negotiation.

+ Ability to prioritize multiple activities and manage ambiguity.

+ Must possessstrong communication (oral, written), organizational, and leadership skills.

Other Information:

+ Initial location at Lilly Technology Center, Indianapolis.

+ Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.

+ Flexibility to work from Indianapolis (or other Lilly sites) may be required throughout 2025 and 2026.

+ Position requires on-site presence and the ability to work in 24 hour manufacturing and laboratory environments.

+ 0-10% travel required.

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

$121,500 - $198,000

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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