Drug Substance Manufacturing Scientist – Advanced Therapies Manufacturing Full-time

Drug Substance Manufacturing Scientist – Advanced Therapies Manufacturing

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

Position Description:

The Drug Substance Manufacturing Scientist – Advanced Therapies Manufacturing role provides technical support for the reliable and compliant manufacture of gene therapy drug substance at external contract manufacturing organizations (CMOs) and, when needed, at LP2, in accordance with global quality standards. This role focuses specifically on drug substance operations — upstream cell culture and bioreactor processes, and downstream purification via chromatography, tangential flow filtration (TFF), and viral filtration.

The role requires daily interaction with external partners, internal process teams, and site management, and will lead technology transfer, process validation, process stewardship, and process monitoring activities. A strong understanding of manufacturing principles is required to ensure consistent standards are applied across internal and external manufacturing sites. The role requires cGMP knowledge, familiarity with applicable global regulatory manufacturing guidance, and the ability to work cross-functionally to deliver technical objectives.

Key Objectives/Deliverables

• Maintain in-depth knowledge of the drug substance process and the control strategy for gene therapy products, including cell culture, bioreactor operation, chromatography, TFF, and viral filtration.
• Provide technical oversight for drug substance manufacturing activities, including technology transfer, process validation, and frontline troubleshooting.
• Lead resolution of technical issues related to control strategy and manufacturing performance.
• Build and maintain working relationships with CMO partners and internal technical organizations.
• Ensure processes are properly characterized, documented, and justified, including alignment of Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) with demonstrated process capability.
• Monitor processes to confirm they remain compliant, capable, in control, and in a validated or qualified state. Identify early signals of process weakness and proactively resolve or escalate.
• Initiate deviation records and drive root cause investigations, ensuring on-time closure with appropriate CAPAs and effectiveness checks.
• Provide technical input to regulatory submissions; author and review annual reports to regulatory agencies.
• Prepare, review, and approve technical documents, including change controls, validation protocols and summary reports, batch records, process description documents, and annual reports.
• Maintain a safe working environment through compliance with safety standards and active participation in safety initiatives.

Basic Requirements:

• B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field
• 3+ years of demonstrated experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS (MSAT), or Engineering functions
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide sponsorship for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 OPT STEM, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1 visa categories.

Additional Preferences:

• Experience with AAV or viral vector gene therapy drug substance manufacturing
• Hands-on or technical oversight experience with chromatography, TFF, or viral filtration purification processes
• Knowledge of applicable regulatory requirements for gene therapy manufacturing
• Experience with data trending and analytics to support process capability assessments (e.g., PAR/NOR alignment)
• Demonstrated project management skills with the ability to coordinate complex, cross-functional initiatives
• Strong communication skills, with the ability to influence diverse technical and business audiences

Additional Information:

• Off-hours support may be needed, by request.
• Required to respond, off shift, to operational issues.
• Minimal 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 for further assistance.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $67,500 – $173,800.

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.