Manufacturing Science Lead — Tech Services & Process Excellence

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Paid time off

Job summary

Eli Lilly and Company is seeking a senior professional to lead deviations investigations, root-cause analysis, and CAPA implementation in drug substance and product manufacturing. You will provide scientific leadership for process monitoring, troubleshooting, and optimization, and collaborate across R&D, Quality, and Regulatory teams.

The role emphasizes technology transfer, process validation strategies, and continued process verification, with mentoring responsibilities within the TS/MS group.

Qualifications

• Bachelor's degree in a related scientific discipline.
• 7+ years in pharma/biotech manufacturing science, process development or technical services.

Responsibilities

• Lead deviations investigations, identify root causes, implement CAPAs.
• Provide scientific/technical leadership for drug substance/product manufacturing, including monitoring, troubleshooting, and optimization.
• Drive CI initiatives to improve process performance, yield, cost, and compliance; define control strategy.
• Support technology transfer for new products/processes/sites; ensure successful implementation.
• Develop and execute process validation strategies, CPV development.
• Prepare technical reports, protocols, and regulatory submission documents (CMC).
• Collaborate with R&D, Quality, Manufacturing, Engineering, and Regulatory.
• Lead or support audits/inspections with technical expertise.
• Mentor junior scientists/engineers within TS/MS team.
• Stay current on industry trends and regulatory requirements in manufacturing science.
• Experience in Radioligand Therapies preferred.

Skills

Problem solving

Communication

Leadership

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's degree in Chemical Engineering / Biotechnology / Biochemistry / Pharmaceutical Sciences

Job description

Eli Lilly and Company is seeking a senior professional to lead deviations investigations, root-cause analysis, and CAPA implementation in drug substance and product manufacturing. You will provide scientific leadership for process monitoring, troubleshooting, and optimization, and collaborate across R&D, Quality, and Regulatory teams.

The role emphasizes technology transfer, process validation strategies, and continued process verification, with mentoring responsibilities within the TS/MS group.