Jobs · Manufacturing · Indiana

Group Leader, Environmental Risk Assessor

BioSpace · Indianapolis, IN · 1 mo ago
Manufacturing$149k–$257k/yrFull-time

About the role

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.

The Environmental Risk Assessment group provides enterprise leadership for environmental risk assessments (ERAs) that support global regulatory submissions, environmental stewardship commitments, and strategic management of issues related to pharmaceuticals in the environment (PiE). Positioned within Lilly’s research and development organization, the group applies scientific judgment to design fit-for-purpose testing strategies for portfolio assets and to anticipate evolving regulatory expectations.

Responsibilities

  • Leads the ERA Group and is accountable for the strategy, quality, and timely delivery of environmental studies and risk assessments that characterize the interaction of Lilly therapeutics with the environment.
  • Serves as a people leader, scientific leader, strategic consultant, and technical expert for PiE‑related issues across Lilly’s portfolio, manufacturing network, regulatory functions, and external engagement forums.
  • Leads the ERA Group by setting scientific direction, developing environmental scientists, and building environmental risk assessment capability across the portfolio.
  • Owns portfolio ERA testing, prioritization, study governance, and submission‑ready delivery for global regulatory registrations.
  • Directs execution of environmental studies that meet regulatory expectations through fit‑for‑purpose CRO partnerships that ensure GLP compliance, data quality, and reliable report delivery.
  • Advances Lilly’s diverse portfolio and ERA science by identifying and fostering innovative solutions and cross‑functional collaboration.
  • Communicates ERA strategy, risks, decisions, and regulatory implications to Lilly leadership, project teams, and regulatory functions.
  • Advises manufacturing on pharmaceutical discharge limits and implementation strategies that protect people, ecosystems, and business continuity.
  • Leads PiE governance by assessing internal and external developments, framing business implications, and driving mitigation strategies through cross‑functional partnership with GHSE, Governmental Affairs, R&D.
  • Represents Lilly externally to benchmark guidelines, influence regulatory expectations, shape industry positions, and

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