Director/Sr Director, Analytical Development & Characterization

Lilly • Indianapolis, IN

2d • $153,000 - $264,000 • Onsite

About The Position

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.

Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
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.

Position Overview:
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