Senior Director, Analytical Development - CMC

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 153,000 - 290,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Health insurance

Flexible benefits

Life insurance

Job summary

Lilly, headquartered in Indianapolis, is seeking a Senior Director of Analytical Development within the CMC group to lead method development, validation, and regulatory strategy for small molecule programs. You will manage external CDMOs, drive phase-appropriate analytical work, and partner with drug substance and product teams across programs.

Strong cGMP knowledge, leadership, and ability to direct outsourced activities are essential.

Qualifications

• Advanced degree required; 10+ years in small molecule pharmaceutical analytics.
• Experience in analytical method development and GMP validation.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Lead analytical strategy for method development, validation, and product characterization across programs.
• Manage third-party CDMOs and transfer of methods from development to regulatory submissions.
• Support regulatory filings (IND, NDA, IMPD) with analytical data and justifications.

Skills

Analytical development

CMC coordination

Project management

Leadership

Outsourced management

Education

PhD in chemistry/pharmaceutical sciences

Job description

Lilly, headquartered in Indianapolis, is seeking a Senior Director of Analytical Development within the CMC group to lead method development, validation, and regulatory strategy for small molecule programs. You will manage external CDMOs, drive phase-appropriate analytical work, and partner with drug substance and product teams across programs.

Strong cGMP knowledge, leadership, and ability to direct outsourced activities are essential.