Director, BR&D Analytics & Development

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 140,000 - 218,000; Full time

Job summary

Eli Lilly and Company, based in Indianapolis, seeks an experienced scientist to lead analytical efforts supporting drug substance and drug product development. The role involves collaboration across Discovery, Development, and Manufacturing to enable clinical trials and regulatory submissions.

The successful candidate will mentor scientific staff, drive analytical strategies, and ensure methods are robust and fit-for-purpose in a fast-paced, onsite lab environment in Indianapolis, IN.

Qualifications

• PhD in Analytical Chemistry or Bioanalytical Chemistry with 5+ years in pharma.
• Experience leading analytical efforts for drug substance and/or drug product development.
• Experience developing global regulatory strategies and authoring regulatory submissions (IND/CTA, BLA/NDA/MAA).
• Mentored and developed scientific staff; managed internal/external projects.

Responsibilities

• Lead analytical efforts for drug substance/product development and regulatory readiness.
• Develop analytical methods, justify specifications, and design stability studies.
• Authors regulatory submissions and responds to questions from global agencies.

Skills

Analytical leadership

Regulatory submissions

Mentoring

Project management

Communication skills

Education

PhD in Analytical Chemistry

MS in Chemistry

BS in Chemistry

Job description

Eli Lilly and Company, based in Indianapolis, seeks an experienced scientist to lead analytical efforts supporting drug substance and drug product development. The role involves collaboration across Discovery, Development, and Manufacturing to enable clinical trials and regulatory submissions.

The successful candidate will mentor scientific staff, drive analytical strategies, and ensure methods are robust and fit-for-purpose in a fast-paced, onsite lab environment in Indianapolis, IN.