Director, Biologics DS Process Development & Tech Transfer

Biopharma Careers; Indianapolis (IN); On-site; USD 153,000 - 264,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Pension

Vacation benefits

Medical/dental/vision

Flexible benefits

Well-being programs

Job summary

Lilly in Indianapolis, Indiana, is seeking a Director to lead biologics drug substance process development focused on downstream purification and CDMO collaboration. The role emphasizes tech transfer, process optimization, and cross-functional CMC activities to accelerate timelines while maintaining quality.

Applicants should hold a PhD with 8+ years in biologics CMC, possess strong communication and leadership skills, and have experience with regulatory filings and external asset due diligence.

Qualifications

• Strong communication, interpersonal, and influencing abilities.
• Experience leading cross-functional CMC teams and external collaborations.
• Track record of improving biologics process development performance.

Responsibilities

• Provide technical leadership for biologics drug substance process development at CDMOs.
• Drive downstream purification process development, scale-up, and GMP execution.
• Lead technology transfer to GMP manufacturing with clear milestones and gates.
• Contribute to regulatory filings and maintain cGMP standards.

Skills

Communication & collaboration

Leadership

Problem solving

Influencing skills

Education

PhD in Chemical/ Biochemical Engineering or related

Job description

Lilly in Indianapolis, Indiana, is seeking a Director to lead biologics drug substance process development focused on downstream purification and CDMO collaboration. The role emphasizes tech transfer, process optimization, and cross-functional CMC activities to accelerate timelines while maintaining quality.

Applicants should hold a PhD with 8+ years in biologics CMC, possess strong communication and leadership skills, and have experience with regulatory filings and external asset due diligence.