Director, Biologics Drug Substance Process & Tech Transfer

Eli Lilly and Company; Indianapolis (IN); On-site; USD 153,000 - 264,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical/dental/vision

Flexible benefits

Life insurance

Time off

Well-being benefits

Job summary

Lilly is seeking a Director to provide technical support for biologics drug substance manufacturing, focusing on downstream purification at CDMOs and accelerating tech transfer with cross-functional teams.

The role includes regulatory-ready CMC contributions, guiding project timelines, and implementing digital tools to improve efficiency while maintaining quality. This leadership position requires a PhD and 8+ years of pharmaceutical experience.

Qualifications

• PhD with 8+ years in pharmaceutical industry.
• Deep knowledge of biologics drug substance process development.
• Hands-on CDMO experience and tech transfer leadership.
• Strong track record of process improvement in biologics CMC.
• Excellent communication and influencing abilities.

Responsibilities

• Provide technical support for biologics drug substance manufacturing at CDMOs, guiding purification process development, scale-up, GMP execution, troubleshooting, deviation review, and batch disposition.
• Identify technical agenda and drive process improvement from testing to implementation.
• Support business development with technical input on CMC packages during due diligence.
• Streamline tech transfer with clear roles, milestones, and risk-managed acceleration.
• Partner with cross-functional teams to develop digital tools and best practices for faster data/document review.
• Apply operational excellence methods including standard work and problem-solving processes.
• Serve as PCTL for external projects, overseeing cross-functional CMC activities.
• Contribute to CMC sections of regulatory filings and ensure compliance with cGMP and Lilly standards.

Skills

CMC knowledge

Biologics process development

Cross-functional collaboration

Regulatory knowledge

GMP experience

Communication skills

Influencing skills

Education

PhD in Chemical Engineering or Biochemical Engineering

Job description

Lilly is seeking a Director to provide technical support for biologics drug substance manufacturing, focusing on downstream purification at CDMOs and accelerating tech transfer with cross-functional teams.

The role includes regulatory-ready CMC contributions, guiding project timelines, and implementing digital tools to improve efficiency while maintaining quality. This leadership position requires a PhD and 8+ years of pharmaceutical experience.