Senior Principal Scientist Process Translation and Execution Lilly Medicine Foundry

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 Function Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a pioneering center that integrates advanced manufacturing and drug development. As the first facility of its kind, the Foundry is designed to accelerate innovation in manufacturing processes, expand capacity for clinical trial medicines, and speed Lilly innovative medicine to Clinics, and reduce both costs and environmental impact.

The Process Translation and Execution (PTE) team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase-appropriate control strategies, and ensures right-first-time clinical manufacturing for a variety of modalities, including synthetic molecules, biologics, peptides, oligonucleotide, and bioconjugates (ADC,ARC etc.)

Through cross-functional collaboration, PTE influences process design, revolutionizes clinical manufacturing, builds capabilities in emerging technologies and aligns with corporate and LRL goals, drives scientific excellence and innovation to accelerate manufacturing advancements and propels the site toward long-term business success.

In the Foundry Construction and Project Delivery/Startup Phase (2025 To 2028), roles will be fluid and dynamic as we build a new organization, design and implement the necessary systems and business processes required to enable operational readiness, support the project delivery, and build the site culture. Success will require significant collaboration, creativity, and resilience as the Lilly Medicine Foundry transitions from design to startup and ultimately to steady-state operations and continuous improvement. This period presents a unique opportunity for learning, growth, and making a lasting impact.

We are seeking enthusiastic scientists and engineers to join the PTE team and help bring the Lilly Medicine Foundry’s vision to life.

Key Responsibilities:

• Tech transfers: Lead or support the transfer of API/DS processes from Process Development (PD) into the cGMP facility. Translate process knowledge and control strategies into manufacturing documentation/procedures; author and review essential tech transfer documentation; conduct facility fit assessments and establish lab models; design and execute needed lab studies to ensure a successful process transfer into GMP production.
• Manufacturing campaign support: Provide on-the-floor support for critical operations, real-time technical expertise during clinical manufacturing campaigns. Daily attendance at process team meeting ideally physically in the control room.
• Process troubleshooting and investigations: Serve as the technical lead for process deviations, quality events, and non-conformances. Perform root cause analysis and develop effective corrective and preventive actions (CAPAs).
• Data Analysis& Process Monitoring: Analyze manufacturing data to monitor process performance, identify trends, and ensure the process remains in a state of control.
• Documentation: Author, review technical documents, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.
• Cross Functional Collaboration: Work with development, manufacturing operations, quality assurance, and regulatory affairs to achieve project and manufacturing goals.
• Process improvement: Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.
• Training/mentoring: Provide training/mentoring to junior scientists, technicians/operators, or in laboratory procedures, data analysis and all PTE activities.

Basic Requirements

• BS or MS in Chemistry, Biology, Biochemistry, Chemical/Biological Engineering, or related disciplines
• Experience: BS with 10+ years, or MS with 7+ years in Pharmaceutical Manufacturing Science and Technology (MSAT), Technical Service Manufacturing Science (TSMS), or Process Development; experience in manufacturing environments for synthetic molecule API, biologics DS is preferred.

Additional Skills and Preferences

• Problem-solving skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
• Communication skills: Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
• Collaboration: Demonstrated success in cross-functional, dynamic, and matrixed environments.
• Regulatory knowledge: Solid understanding of biopharmaceutical manufacturing principles and cGMP requirements.
• Project management: Experience leading small projects, coordinating activities, and managing timelines to meet project goals.

Other Information:

• Initial location at Lilly Technology Center, Indianapolis.
• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
• Limited domestic and international travel (< 5%) may be required for this role
• Role requires ability to work in manufacturing and laboratory environments.

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

$79,500 - $171,600

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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