Associate Director - Operations Process Lead

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.

We are seeking a highly motivated and experienced Process Lead to optimize and manage operational processes within Eli Lilly Radioligand Therapies. This role will drive continuous improvement initiatives, ensuring efficiency, compliance, and excellence across our manufacturing and supply chain operations.

** Responsibilities:*
* + Analyze processes to identify bottlenecks and implement solutions that 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 and participate in root cause analysis, 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.

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* Basic Qualifications:

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* + Bachelor's degree in Engineering (Chemical, Industrial, Biomedical, or related field), Pharmaceutical Sciences, or a related scientific discipline.

+ 7+ years of experience in process engineering, operations management, or a similar role within pharmaceutical or biotechnology manufacturing; experience with RLT (Radioligand Therapy) highly preferred.

** Additional Preferences*
* + Proven track record leading process improvement initiatives with measurable results, including experience with process validation and change control.

+ Strong knowledge of cGMP, FDA guidelines, and relevant industry standards.

+ Proficiency in process mapping, SPC, Lean, and Six Sigma methodologies (Green/Black Belt certification a plus).

+ Strong analytical, problem-solving, and decision-making abilities.

+ Excellent communication and interpersonal skills, with the ability to lead and influence cross-functional teams.

+ Proficiency with relevant software tools (e.g., process simulation, data analysis, project management).

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. 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.

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