Director/Sr Director, Analytical Development & Characterization

Eli Lilly and Company • Us, IN

1d • Onsite

About The Position

The Drug Delivery group at Lilly studies physiological barriers across routes of administration to create novel, patient-centric delivery solutions, serving as a center of excellence in injection physiology, device ideation, novel drug delivery technologies across modalities and routes of administration, nanomedicine and targeted delivery, and connected devices/digital biomarkers. The Director/Sr Director, Analytical Development & Characterization anchors the analytical development and characterization capability that underpins these platforms — spanning separation science and method development and validation (stability-indicating, impurity, potency, and identity methods), in vitro release and dissolution science for long-acting and controlled-release systems, and the physicochemical and biophysical characterization of complex injectable, particulate, and nanoparticle dosage forms (particle sizing, solution behavior, thermal and higher-order structural stability, and the bio-nano interface) — intended to define critical quality attributes, build phase-appropriate control strategies, and de-risk the translation of injectable biologics, peptides, and nucleic-acid medicines. We are seeking a senior technical leader to define and drive the analytical scientific and translational strategy for these platforms at Lilly, operating at the enterprise level: setting technical direction across programs, representing Lilly externally with academic, CDMO, and regulatory stakeholders, and mentoring the next generation of scientists and engineers. The role carries accountability for translating delivery-science analytical understanding from method and characterization science into IND- and CMC-ready control strategies and delivery platforms.

Requirements

• Earned PhD in analytical chemistry, pharmaceutical sciences, chemistry, chemical engineering, or a related field.
• 8+ years of relevant industry/translational experience in pharmaceutical analytical development, including demonstrated depth in separation science (HPLC/UPLC, LC-MS) and method development and validation (stability-indicating and impurity methods, and the definition of critical quality attributes and phase-appropriate control strategies).
• Demonstrated ability to bridge analytical method and characterization science — or a directly comparable analytical/CMC discipline — into IND-enabling or CMC-ready control strategies, supported by working knowledge of method validation (ICH Q2), design controls, and quality systems in a regulated industry
• Effective, hands-on use of AI/ML-enabled tools (e.g., large language models, computational modeling copilots, literature-synthesis or data-analysis assistants) to accelerate scientific research, technical writing, and translational planning
• Proven ability to lead, mentor, and develop technical talent, including staff outside a direct reporting line
• A publication and/or patent record demonstrating recognized technical contribution in analytical development or characterization science; and excellent scientific communication skills across technical/non-technical and internal/external audiences.

Nice To Haves

• Experience building and sustaining external scientific relationships (academic labs, consortia, key opinion leaders); comfort representing an organization's technical position externally.
• Experience with analytical development for complex or novel delivery systems (long-acting injectables/depots, nanoparticles/LNPs, high-concentration biologics, peptides, or transdermal systems), in vitro release/dissolution method development, or proteomics/LC-MS characterization of the nano-bio interface, is a plus but not required if compensated by deep analytical/method-development expertise.

Responsibilities

• Define the scientific vision and multi-year technical strategy for analytical development and characterization across the delivery-science portfolio, aligned with the group's portfolio bets and enterprise R&D priorities, including build-vs-buy and external innovation decisions (licensing, partnerships, sponsored research).
• Serve as Lilly's internal and external technical authority on delivery-science analytical development — including chromatographic and orthogonal method development and validation, in vitro release/dissolution and IVIVC-enabling analytics, and physicochemical, biophysical, and bio-nano-interface characterization; lead cross-functional and cross-company teams to translate methods and control strategies from feasibility through design control and CMC, leveraging AI/ML-enabled modeling and data-analysis tools to accelerate technical decision-making.
• Build and leverage an external network of academic collaborators, CDMOs, consortia, and regulatory bodies (e.g., FDA, USP/ICH standards efforts); represent Lilly's analytical development and characterization work in publications, conferences, and regulatory or compendial discussions.
• Design and oversee analytical method, release-characterization, and stability study strategy with CRO/CDMO and academic partners to de-risk IND-enabling and CMC decisions; champion breakthrough approaches and make data-driven, sometimes bold, decisions under scientific and technical ambiguity where no precedent exists.
• Actively mentor and coach scientists and engineers, including staff outside your direct reporting line; identify and help lead scientific or process improvements that draw on diverse thinking across DDCS's broader technical portfolio.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree