Director, Early-Phase API Process Development

Eli Lilly and Company; Indianapolis (IN); Presencial; USD 153.000 - 264.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Descripción de la vacante

Lilly in Indianapolis seeks experienced scientists to lead synthetic molecule route development and unit operation definition for preclinical to Phase 2 studies. You will guide teams of process chemists, analytical chemists, and engineers to advance drug candidates and support regulatory submissions.

The role includes oversight of external R&D, tech transfer, and campaign execution. Strong expertise in modern analytics, PAT, and scale-up is essential to deliver robust manufacturing processes.

Formación

• Ph.D. in organic chemistry or related field with 8+ years of process development experience OR MS with 15+ years' experience.
• Experience with regulatory submissions and responses to regulatory questions.

Responsabilidades

• Lead synthetic molecule route development and unit operation definition for drug candidates.
• Provide oversight for external R&D, tech transfer, and campaign execution.
• Collaborate across CMC networks to support clinical trials and regulatory submissions.

Conocimientos

Process chemistry

Regulatory submissions

Team leadership

Analytical techniques

PAT

Educación

Ph.D. in organic chemistry

MS in Organic Chemistry

Herramientas

Modeling & simulation tools

Data analytics

Descripción del empleo

Lilly in Indianapolis seeks experienced scientists to lead synthetic molecule route development and unit operation definition for preclinical to Phase 2 studies. You will guide teams of process chemists, analytical chemists, and engineers to advance drug candidates and support regulatory submissions.

The role includes oversight of external R&D, tech transfer, and campaign execution. Strong expertise in modern analytics, PAT, and scale-up is essential to deliver robust manufacturing processes.