Senior Director, Advanced Therapies Manufacturing Science

Eli Lilly and Company; Indianapolis (IN); On-site; USD 152,000 - 264,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Job summary

Lilly in Indianapolis, IN is seeking a Senior Advisor / Director – Technical Services/Manufacturing Science for Advanced Therapies. You will lead technical strategy across viral vector and lipid nanoparticle modalities.

The role involves partnering with development, manufacturing, quality, and regulatory teams, guiding tech transfer, process validation, and lifecycle support, with global scope and travel up to 30%.

Qualifications

• Master’s or PhD in biochemistry, molecular biology, chemical engineering, biotechnology, pharmaceutical sciences, or related field.
• Minimum 8 years in biopharmaceutical drug substance manufacturing or GMP environment.
• Hands-on experience with advanced therapy drug substance—viral vectors or non-viral delivery; breadth across platforms preferred.

Responsibilities

• Lead technical strategy for assigned advanced therapy drug substance programs through development to lifecycle management.
• Represent TS/MS on cross-functional teams for manufacturing readiness, process validation, and governance.
• Provide technical oversight of external contract manufacturers, including tech transfer and comparability assessments.
• Author/review CMC sections of regulatory submissions and support health authority interactions.
• Lead viral vector and lipid nanoparticle manufacturing challenges, including process analytics and cryogenic handling considerations.
• Mentor scientists and engineers across Lilly to advance platform knowledge and technical rigor.
• Drive investigations and significant change controls with high risk or complexity; ensure state of control with QA/QC partners.

Skills

Advanced therapy manufacturing

GMP experience

External vendor oversight

Regulatory submissions

Cross-functional leadership

Mentoring/teaching

Data-driven problem solving

Education

Master’s or PhD in biochemistry/biotech/related

Job description

Lilly in Indianapolis, IN is seeking a Senior Advisor / Director – Technical Services/Manufacturing Science for Advanced Therapies. You will lead technical strategy across viral vector and lipid nanoparticle modalities.

The role involves partnering with development, manufacturing, quality, and regulatory teams, guiding tech transfer, process validation, and lifecycle support, with global scope and travel up to 30%.