Senior Director, Biologics Purification & CMC Strategy

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 156,000 - 229,000; Full time

Benefits offered by this job

401(k) plan

Pension

Medical, dental, vision

Well-being program

Job summary

Eli Lilly and Company is seeking a Senior Director to lead purification CMC for biologics. You will guide downstream development, scale-up, viral clearance strategy, and tech transfer for a diverse bioproduct portfolio, collaborating across Discovery, Manufacturing, and Regulatory to advance programs toward regulatory approval.

The ideal candidate will drive innovation, manage a 10+ person team, and oversee lab operations with a strong emphasis on safety and regulatory readiness.

Qualifications

• Ph.D. in Chemistry, Biochemistry, Chemical Engineering or related field with 10+ years in pharma.
• Strong bioproduct development knowledge from candidate selection through regulatory submission.
• Proven track record of technology innovation in downstream bioprocessing or related CMC areas.

Responsibilities

• Leads purification development including viral safety to enable scale-up and tech transfer.
• Sets strategic direction for the department and ensures portfolio growth.
• Oversees emergence of new technologies and regulates their implementation.
• Defines innovation roadmap aligned with discovery and manufacturing needs.
• Allocates resources to meet portfolio demands and drive productivity.
• Leads adoption of AI/ML tools and high-throughput workflows.
• Develops talent and coaches team of 10+ scientists.
• Oversees lab operations and scale-up facilities with safety focus.

Skills

Downstream bioprocessing

Biologics CMC

Technology transfer

Team leadership

Regulatory submissions

Viral safety

AI/ML tools

Education

Ph.D. in Chemistry/Biochemistry/Chemical Engineering

M.S. in a related field

Tools

Process modeling software

Regulatory filing software

Job description

Eli Lilly and Company is seeking a Senior Director to lead purification CMC for biologics. You will guide downstream development, scale-up, viral clearance strategy, and tech transfer for a diverse bioproduct portfolio, collaborating across Discovery, Manufacturing, and Regulatory to advance programs toward regulatory approval.

The ideal candidate will drive innovation, manage a 10+ person team, and oversee lab operations with a strong emphasis on safety and regulatory readiness.