Senior Director, CMC Analytical Development (Small Molecules)

Eli Lilly and Company; États-Unis; À distance; USD 153 000 - 290 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Well-being benefits

Résumé du poste

Centessa Pharmaceuticals, a subsidiary of Eli Lilly, is seeking a Senior Director of Analytical Development within the CMC group. The role leads method development, validation, and strategy across multiple programs, coordinating external CDMOs and cross‑functional teams to ensure regulatory-ready data.

The candidate will oversee analytical data from drug substance to drug product, drive cGMP compliance, and manage stability and release testing. Travel domestically and internationally is required.

Qualifications

• PhD in chemistry, pharmaceutical sciences or related field (strongly preferred)
• Hands-on analytical development experience for small molecule oral solid dosage forms
• Extensive GMP experience and regulatory knowledge for pharma products
• Experience managing outsourced analytical activities with CDMOs
• Strong project management and cross-functional leadership
• Ability to review and interpret validation data and regulatory submissions
• Experience with stability programs and batch release
• Ability to work in fast-paced multi-program environments

Responsabilités

• Lead analytical strategy for method development, validation, and product characterization across programs
• Coordinate outsourced analytical development at third-party vendors (CDMOs)
• Review method validation protocols/reports and test data for release and stability
• Generate stability data tables and file expiry/shelf-life assignments
• Set specifications based on batch history and data
• Act as CMC analytical representative in program teams
• Mentor junior analytical scientists and lead in regulatory filings
• Support investigations and nonconformities with Quality
• Contribute to regulatory submissions (IND, NDA, ANDA, etc.)
• Review internal reports for analytical sections in global submissions
• Collaborate with QA on investigations and deviations
• Participate in batch record reviews

Connaissances

Analytical method development

GMP qualification/validation

Outsourced analytical activities

Project management

Cross-functional collaboration

Regulatory guidance understanding

Analytical characterization

Leadership

Formation

PhD preferred

Advanced degree in chemistry or pharmaceutical sciences

Description du poste

Centessa Pharmaceuticals, a subsidiary of Eli Lilly, is seeking a Senior Director of Analytical Development within the CMC group. The role leads method development, validation, and strategy across multiple programs, coordinating external CDMOs and cross‑functional teams to ensure regulatory-ready data.

The candidate will oversee analytical data from drug substance to drug product, drive cGMP compliance, and manage stability and release testing. Travel domestically and internationally is required.