Sr. Director-Purification and Viral Safety
Eli Lilly and Company
7 hours ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Lead purification development and viral safety CMC to enable development, scale-up, and technology transfer for early- and late-stage bioproduct portfolios.
- Establish and drive the department’s strategic direction; ensure strong execution to support portfolio growth and organizational objectives.
- Oversee adoption of emerging technologies and evolving regulatory initiatives; ensure effective implementation.
- Define and drive innovation strategy and roadmap aligned with Discovery and manufacturing needs.
- Proactively reallocate resources to respond to changing portfolio demands and improve productivity through operational excellence.
- Lead adoption/integration of AI/ML tools, process modeling, and high-throughput screening to advance purification and viral safety workflows.
- Develop talent, including coaching and performance management.
- Oversee development lab operations (including scale-up facility) with a focus on workplace safety.
- Collaborate across departments to ensure overall 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.
- Strong track record of downstream bioprocessing or viral safety technology innovation.
- Excellent communication, interpersonal, and leadership skills.
- Demonstrated experience leading high-performance scientific teams.
Additional Preferences:
- End-to-end biologics CMC experience (upstream, analytical, formulation) and hands-on regulatory filing for early- and late-stage programs.
- Experience with GMP implementation and manufacturing technology transfer/facility fit.
- Experience collaborating across the bioproduct portfolio.
- Experience leveraging AI tools to improve CMC workflow efficiency.
Benefits:
- Eligible for company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life insurance, time off/leave, and well-being benefits.
Travel/Environment:
- Lab environment; travel <10%.
Application instruction:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
- Lead purification development and viral safety CMC to enable development, scale-up, and technology transfer for early- and late-stage bioproduct portfolios.
- Establish and drive the department’s strategic direction; ensure strong execution to support portfolio growth and organizational objectives.
- Oversee adoption of emerging technologies and evolving regulatory initiatives; ensure effective implementation.
- Define and drive innovation strategy and roadmap aligned with Discovery and manufacturing needs.
- Proactively reallocate resources to respond to changing portfolio demands and improve productivity through operational excellence.
- Lead adoption/integration of AI/ML tools, process modeling, and high-throughput screening to advance purification and viral safety workflows.
- Develop talent, including coaching and performance management.
- Oversee development lab operations (including scale-up facility) with a focus on workplace safety.
- Collaborate across departments to ensure overall 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.
- Strong track record of downstream bioprocessing or viral safety technology innovation.
- Excellent communication, interpersonal, and leadership skills.
- Demonstrated experience leading high-performance scientific teams.
Additional Preferences:
- End-to-end biologics CMC experience (upstream, analytical, formulation) and hands-on regulatory filing for early- and late-stage programs.
- Experience with GMP implementation and manufacturing technology transfer/facility fit.
- Experience collaborating across the bioproduct portfolio.
- Experience leveraging AI tools to improve CMC workflow efficiency.
Benefits:
- Eligible for company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life insurance, time off/leave, and well-being benefits.
Travel/Environment:
- Lab environment; travel <10%.
Application instruction:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.