Sr. Director-Purification and Viral Safety

About the role

Lilly, a global healthcare leader, seeks a Senior Director to lead the purification and viral safety CMC function for biologics products. This role is accountable for downstream process development, scale-up, viral clearance strategy, technology transfer, and regulatory submissions for various bioproduct programs.

Responsibilities

• Leads the purification development and viral safety department to enable development, scale-up, and technology transfer for both early- and late-stage bioproduct portfolios.
• Establishes and drives the strategic direction of the department, ensuring strong execution to support portfolio growth and meet organizational objectives.
• Provides oversight to ensure the department stays current with emerging technologies, capabilities, and evolving regulatory initiatives, and leads their effective implementation.
• Defines and drives innovation strategy and roadmap to ensure competitiveness and alignment with Discovery and manufacturing needs.
• Proactively reallocates resources to respond to changing portfolio demands, including program acceleration, while driving productivity through operational excellence.
• Leads the adoption and integration of AI/ML tools, process modeling, and high-throughput screening to advance purification and viral safety workflows.
• Develops talent at all levels and ensures effective coaching and performance management.
• Oversees development laboratory operations, including the scale-up facility, with a strong focus on workplace safety.
• Collaborates closely with leaders across departments to ensure overall business effectiveness.

Requirements

• Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or related fields, with a minimum of 10 years of pharmaceutical industry experience, or BS/MS with 18+ years of applicable experience.
• Deep knowledge of bioproduct development from candidate selection through regulatory submission.
• Strong track record of technology innovation in downstream bioprocessing or viral safety.
• Excellent communication, interpersonal, and strong leadership skills are essential.
• Demonstrated experience leading high-performance scientific teams.

Additional Preferences

• Demonstrated experience across end-to-end biologics CMC workflows, with broad knowledge of upstream, analytical, and formulation functions and hands-on regulatory filing experience for early- and late-stage programs.
• Experience collaborating with Manufacturing on GMP implementation, including technology transfer and facility fit.
• Proven ability to collaborate with partners to ensure effective oversight across the entire bioproduct portfolio.
• Experience leveraging AI tools to improve efficiency in CMC workflows.