Director, Biologics Drug Substance Process Development

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 Bioproduct Research and Development (BR&D) team is seeking a Director to provide technical support for our growing pipelines with increasing complexity while delivering against accelerated timelines. In particular, this role will support biologics drug substance manufacturing at CDMOs, with an emphasis on downstream purification, including post-conjugation purification. In addition to technical oversight and cross-functional collaborations to advance projects, this role streamlines and simplifies the overall tech transfer process and works with partner functions to develop and incorporate digital tools and best practices that accelerate the path from initiation to final data and document review, raising efficiency without compromising quality.

The role may also serve as PCTL, overseeing cross-functional CMC activities beyond drug substance.

Responsibilities:

+ Provides technical support for biologics drug substance manufacturing at CDMOs, including guiding purification process development, scale-up, GMP execution, troubleshooting, deviation review, and batch disposition.

+ Identify the technical agenda and innovation ideas for process improvement. Develop and drive novel solutions from testing to implementation.

+ Support business development by providing technical input on the CMC package of external assets during due diligence.

+ Streamlines the tech transfer process through clear role definition, a structure framework with milestones and decision gates, and the flexibility needed for acceleration while controlling risk.

+ Partner with cross-functional teams to develop digital tools and best practices that speed the path from initiation to final data and document review, raising productivity without compromising quality.

+ Applies operational excellence methods for continuous improvement, including standard work, problem solving processes, and translating lessons learned into updated standards.

+ Serves as PCTL when needed, particularly for external projects, overseeing cross-functional CMC activities.

+ Contributes to CMC sections of regulatory filings and ensures external activities meet cGMP and Lilly quality standards.

Basic Requirements:

+  PhD in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field with 8+ years of pharmaceutical industry experience.

+ Deep knowledge of biologics drug substance process development, including downstream purification, through regulatory submission.

+ Hands-on experience working with CDMOs and leading technology transfer to GMP manufacturing.

+ Strong track record of improving process performance or introducing new technology in biologics CMC.

+ Excellent communication, interpersonal, and influencing skills.

Additional Preferences:

+ Demonstrated use of operational excellence methods with measurable results.

+ Experience putting digital, data-driven, or AI tools into practice to improve efficiency in CMC workflows.

+ Experience leading cross-functional CMC teams or a similar project leadership role.

+ Familiarity with regulatory filing requirements for biologics (for example IND and BLA) and comparability requirements.

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