Senior Director, CMC Analytical Development

BioSpace; Indianapolis (IN); On-site; USD 153,000 - 290,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Pension

Paid time off

Job summary

Lilly, headquartered in Indianapolis, seeks a Senior Director of Analytical Development to lead phase‑appropriate method development and product characterization across multiple programs. You will drive strategy, manage external CDMO collaborations, and ensure data integrity for regulatory filings while mentoring junior staff.

The role emphasizes strong cGMP knowledge, cross‑functional collaboration, and global regulatory awareness in a fast‑paced environment. Based in the US with some travel.

Qualifications

• Advanced degree in chemistry or pharmaceutical sciences (PhD preferred).
• 10+ years in small molecule pharmaceutical industry.
• Experience in early phase analytical development and cGMP regulatory requirements.

Responsibilities

• Lead analytical strategy across phase-appropriate method development and product characterization.
• Oversee third‑party vendor work (CDMOs) for method transfer, qualification, validation, and stability testing.
• Review validation data and test results for release, stability, and characterization.
• Coordinate documentation and data packages for regulatory submissions (IND, NDA, etc).
• Collaborate with Quality on investigations and OOE/OOT/OOS events.
• Mentor junior analytical scientists and represent CMC in cross‑functional teams.
• Drive regulatory filings support including justifications and dissolution method development.

Skills

Analytical development

cGMP knowledge

Regulatory familiarity

Project management

Leadership

Education

PhD in chemistry

Job description

Lilly, headquartered in Indianapolis, seeks a Senior Director of Analytical Development to lead phase‑appropriate method development and product characterization across multiple programs. You will drive strategy, manage external CDMO collaborations, and ensure data integrity for regulatory filings while mentoring junior staff.

The role emphasizes strong cGMP knowledge, cross‑functional collaboration, and global regulatory awareness in a fast‑paced environment. Based in the US with some travel.