Director, Biologics DS Process Innovation

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

Benefits offered by this job

Company bonus program

401(k) plan

Medical, dental, vision benefits

Flexible benefits

Job summary

Lilly in Indianapolis is seeking a Director to provide technical leadership for biologics drug substance manufacturing, focusing on downstream purification and transfer to GMP manufacturing. The role drives process improvements, supports due diligence, and oversees cross-functional CMC activities across external assets.

You will collaborate with CDMOs, develop digital tools to accelerate data and document reviews, and ensure adherence to cGMP and Lilly quality standards while delivering on

Qualifications

• PhD in a relevant field with 8+ years pharma experience.
• Deep knowledge of biologics drug substance process development.
• Hands-on experience with CDMOs and tech transfer to GMP manufacturing.
• Strong track record of improving process performance in biologics CMC.
• Excellent communication and collaboration skills.

Responsibilities

• Provide technical support for biologics drug substance manufacturing at CDMOs, including purification process development, scale-up, GMP execution, troubleshooting.
• Identify technical agenda and drive novel process improvements.
• Support due diligence with technical input on the CMC package of external assets.
• Streamline the tech transfer process with milestones and decision gates.
• Partner with cross-functional teams to develop digital tools and best practices that speed data and document review.
• Apply operational excellence methods for continuous improvement.
• Serve as PCTL when needed for external projects.
• Contribute to CMC sections of regulatory filings and ensure compliance with cGMP and Lilly standards.

Skills

Communication

Interpersonal skills

Influencing

Education

PhD in Chemical/Biochemical Engineering or Biochemistry

Job description

Lilly in Indianapolis is seeking a Director to provide technical leadership for biologics drug substance manufacturing, focusing on downstream purification and transfer to GMP manufacturing. The role drives process improvements, supports due diligence, and oversees cross-functional CMC activities across external assets.

You will collaborate with CDMOs, develop digital tools to accelerate data and document reviews, and ensure adherence to cGMP and Lilly quality standards while delivering on