Director, Early-Phase Process Chemistry & API Development

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 149,000 - 257,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Well-being benefits

Job summary

Lilly in Indianapolis is seeking an experienced leader to oversee synthetic molecule route commercialization, process optimization, and unit operation definition for drug candidates advancing to clinical trials and commercialization. You will guide teams across chemistry, analytics, formulation, and engineering, and provide oversight for external R&D and tech transfer.

You will drive collaboration with CMC, support regulatory submissions, and ensure robust, scalable processes while leveraging

Qualifications

• Ph.D. in organic chemistry or a related field with 10+ years of pharmaceutical process development experience.
• Alternatively, an MS in Organic Chemistry or related field with 15+ years' experience.
• Experience with regulatory submissions and tech transfer is preferred.

Responsibilities

• Lead synthetic molecule route commercialization and process optimization.
• Provide oversight for external R&D and tech transfer.
• Lead cross-disciplinary teams of process chemists, analytical chemists, formulation scientists, and engineers.
• Collaborate with CMC networks to support clinical trials and regulatory submissions.

Skills

Leadership capabilities

Communication skills

Collaboration

Project management

Analytical techniques

Modeling and simulation tools

Education

Ph.D. in organic chemistry or related field

MS in Organic Chemistry or related field with 15+ years' experience

Tools

Regulatory submission experience

Technology transfer systems

Job description

Lilly in Indianapolis is seeking an experienced leader to oversee synthetic molecule route commercialization, process optimization, and unit operation definition for drug candidates advancing to clinical trials and commercialization. You will guide teams across chemistry, analytics, formulation, and engineering, and provide oversight for external R&D and tech transfer.

You will drive collaboration with CMC, support regulatory submissions, and ensure robust, scalable processes while leveraging