Position Description: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 STEM OPT, 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.
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.
#WeAreLilly
