Senior Process Lead, Pharmaceutical Operations

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 119,000 - 174,000; Full time

Job summary

Lilly, headquartered in Indianapolis, seeks a Process Lead to optimize and manage operational processes within Radioligand Therapies. You will drive continuous improvement across manufacturing and supply chain, ensuring efficiency, quality, and compliance while guiding junior staff.

Responsibilities include leading process design, documentation, documentation validation, root cause analysis, and cross-functional collaboration with QA, Manufacturing, and HSE.

Qualifications

• Bachelor's degree in Engineering or related field.
• 7+ years in process engineering, operations management in pharma/biotech.
• Experience with Radioligand Therapy (RLT) is highly preferred.

Responsibilities

• Analyze processes to identify bottlenecks and implement solutions to improve efficiency, quality, and waste reduction.
• Lead design, development, and continuous improvement of operational processes in compliance with cGMP and regulatory requirements.
• Own process documentation (SOPs, work instructions, process flow diagrams) and validation activities, including strategy, protocols, and approvals.
• Lead root cause analyses, CAPAs, deviations, investigations, and change controls to support compliance performance.
• Partner cross-functionally with HSE‑RS, TSMS, Manufacturing, QA, and Supply Chain to ensure seamless process integration and execution.
• Support internal and external audits, ensuring timely closure of quality and safety compliance activities.
• Track and report KPIs/metrics, identifying trends and recommending adjustments to meet business objectives.
• Provide technical guidance and mentorship to junior engineers and operational staff, fostering a culture of continuous improvement.

Skills

Analytical thinking

Problem solving

Cross-functional collaboration

Process mapping

Lean Six Sigma

Education

Bachelor's degree in Engineering or related field

Tools

Process simulation

Data analysis

Project management

Job description

Lilly, headquartered in Indianapolis, seeks a Process Lead to optimize and manage operational processes within Radioligand Therapies. You will drive continuous improvement across manufacturing and supply chain, ensuring efficiency, quality, and compliance while guiding junior staff.

Responsibilities include leading process design, documentation, documentation validation, root cause analysis, and cross-functional collaboration with QA, Manufacturing, and HSE.