Senior Director, Biologics Purification & CMC Strategy

BioSpace; Indianapolis (IN); On-site; USD 156,000 - 229,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical/dental/vision

Flexible benefits

Life insurance

Job summary

Lilly in Indianapolis seeks a Senior Director to lead the purification CMC function for biologics. You will oversee downstream process development, scale-up, viral clearance strategy, technology transfer, and regulatory submissions across a bioproduct portfolio.

Collaborate across Discovery, Manufacturing, and Regulatory to advance programs from preclinical to registration. You will drive innovation, manage a 10+ team, and integrate AI/ML tools and high-throughput screening to improve

Qualifications

• Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or related field with 10+ years pharma experience.
• Deep knowledge of bioproduct development from candidate selection through regulatory submission.
• Experience leading 10+ scientists in high-performance teams.

Responsibilities

• Leads purification development including viral safety for early- and late-stage bioproducts.
• Sets strategic direction of the department and ensures execution to meet objectives.
• Drives innovation with AI/ML, process modeling, and high-throughput screening.

Skills

Leadership

Strategic thinking

Communication

Downstream bioprocessing

Technology transfer

AI/ML tools

Education

Ph.D. in Chemistry/Biochemistry/Chemical Engineering

M.S. with 18+ years of experience

Tools

AI/ML tools

Process modeling software

Job description

Lilly in Indianapolis seeks a Senior Director to lead the purification CMC function for biologics. You will oversee downstream process development, scale-up, viral clearance strategy, technology transfer, and regulatory submissions across a bioproduct portfolio.

Collaborate across Discovery, Manufacturing, and Regulatory to advance programs from preclinical to registration. You will drive innovation, manage a 10+ team, and integrate AI/ML tools and high-throughput screening to improve