Associate Director - Operations Process Lead

Lilly•Indianapolis, IN
•$118,500 - $173,800•Onsite

About The Position

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.

Requirements

  • 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.

Nice To Haves

  • 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).

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.

Benefits

  • company bonus (depending, in part, on company and individual performance)
  • company-sponsored 401(k)
  • pension
  • vacation benefits
  • medical benefits
  • dental benefits
  • vision benefits
  • prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance
  • death benefits
  • certain time off and leave of absence benefits
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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