Director of Analytical Development & Characterization

100 Eli Lilly and Company; United States; On-site; USD 153,000 - 264,000; Full time

Benefits offered by this job

401(k) plan

Pension

Health, dental, vision benefits

Flexible vacation policy

Job summary

Lilly is seeking a Director/Sr Director of Analytical Development & Characterization to define and drive analytics strategy for injectable biologics and complex dosage forms. You will guide method development, stability and impurity testing, and IVIVC‑enabling analytics, coordinating with CROs/CDMOs and internal teams.

You will mentor staff, represent Lilly externally, and advance data‑driven decision making using AI/ML tools, with 25–50% travel and broad regulatory engagement.

Qualifications

• PhD in analytical chemistry, pharmaceutical sciences or related field.
• 8+ years in pharmaceutical analytical development with separation science experience.
• Bridge analytical method work to IND/CMC strategies and quality systems.

Responsibilities

• Define multi‑year strategy for analytical development and characterization.
• Lead cross‑functional teams to translate methods into CMC deliverables.
• Mentor scientists and represent Lilly externally with collaborators.
• Oversee method and release‑characterization studies with CROs/CDMOs.
• Champion data‑driven decisions using AI/ML in translational planning.

Skills

Analytical chemistry

Method development

HPLC/UPLC

LC‑MS

IND/CMC strategy

Team leadership

Mentoring

AI/ML analytics

Education

PhD in analytical chemistry or related field

Tools

HPLC

LC‑MS

Job description

Lilly is seeking a Director/Sr Director of Analytical Development & Characterization to define and drive analytics strategy for injectable biologics and complex dosage forms. You will guide method development, stability and impurity testing, and IVIVC‑enabling analytics, coordinating with CROs/CDMOs and internal teams.

You will mentor staff, represent Lilly externally, and advance data‑driven decision making using AI/ML tools, with 25–50% travel and broad regulatory engagement.