Sr. Director-Purification and Viral Safety
Eli Lilly and Company
August 24, 2026
On-site
Indianapolis, IN
Operations
Organization And Position Summary
Bioproduct Research and Development (BRD) seeks a Senior Director to lead purification and viral safety CMC for biologics products. Accountable for downstream process development (scale-up, viral clearance strategy, technology transfer, and regulatory submissions) across a portfolio including monoclonal antibodies, bispecific antibodies, recombinant proteins, AAV, and bioconjugates. Collaborates with Discovery, Manufacturing, and Regulatory from preclinical development through successful registration.
Responsibilities
- Lead purification development and viral safety to enable development, scale-up, and technology transfer for early- and late-stage portfolios.
- Establish and drive departmental strategy to support portfolio growth and organizational objectives.
- Oversee emerging technologies and evolving regulatory initiatives; ensure effective implementation.
- Define and drive innovation strategy/roadmap aligned with Discovery and manufacturing needs.
- Reallocate resources to respond to portfolio demands, including program acceleration, while driving operational excellence.
- Lead adoption/integration of AI/ML tools, process modeling, and high-throughput screening to advance workflows.
- Develop talent; coach and manage performance.
- Oversee development laboratory operations, including the scale-up facility, with a focus on workplace safety.
- Collaborate across departments to ensure business effectiveness.
Basic Requirements
- Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or related field with 10+ years pharmaceutical industry experience, or BS/MS with 18+ years applicable experience.
- Deep knowledge of bioproduct development from candidate selection through regulatory submission.
- Track record of technology innovation in downstream bioprocessing or viral safety.
- Excellent communication, interpersonal, and leadership skills.
- Experience leading high-performance scientific teams.
Additional Preferences
- End-to-end biologics CMC workflow experience; broad upstream/analytical/formulation knowledge; hands-on regulatory filing for early- and late-stage programs.
- GMP implementation collaboration with Manufacturing (technology transfer, facility fit).
- Ability to collaborate across the bioproduct portfolio.
- Experience leveraging AI tools to improve CMC efficiency.
Bioproduct Research and Development (BRD) seeks a Senior Director to lead purification and viral safety CMC for biologics products. Accountable for downstream process development (scale-up, viral clearance strategy, technology transfer, and regulatory submissions) across a portfolio including monoclonal antibodies, bispecific antibodies, recombinant proteins, AAV, and bioconjugates. Collaborates with Discovery, Manufacturing, and Regulatory from preclinical development through successful registration.
Responsibilities
- Lead purification development and viral safety to enable development, scale-up, and technology transfer for early- and late-stage portfolios.
- Establish and drive departmental strategy to support portfolio growth and organizational objectives.
- Oversee emerging technologies and evolving regulatory initiatives; ensure effective implementation.
- Define and drive innovation strategy/roadmap aligned with Discovery and manufacturing needs.
- Reallocate resources to respond to portfolio demands, including program acceleration, while driving operational excellence.
- Lead adoption/integration of AI/ML tools, process modeling, and high-throughput screening to advance workflows.
- Develop talent; coach and manage performance.
- Oversee development laboratory operations, including the scale-up facility, with a focus on workplace safety.
- Collaborate across departments to ensure business effectiveness.
Basic Requirements
- Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or related field with 10+ years pharmaceutical industry experience, or BS/MS with 18+ years applicable experience.
- Deep knowledge of bioproduct development from candidate selection through regulatory submission.
- Track record of technology innovation in downstream bioprocessing or viral safety.
- Excellent communication, interpersonal, and leadership skills.
- Experience leading high-performance scientific teams.
Additional Preferences
- End-to-end biologics CMC workflow experience; broad upstream/analytical/formulation knowledge; hands-on regulatory filing for early- and late-stage programs.
- GMP implementation collaboration with Manufacturing (technology transfer, facility fit).
- Ability to collaborate across the bioproduct portfolio.
- Experience leveraging AI tools to improve CMC efficiency.