Sr. Director-Purification and Viral Safety

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Bioproduct Research and Development (BRD) is seeking a Senior Director to lead the purification and viral safety CMC function for biologics products. This position is accountable for downstream process development including scale-up, viral clearance strategy, technology transfer, and regulatory submissions for a broad portfolio of bioproduct programs, including, but not limited to, monoclonal antibodies, bispecific antibodies, recombinant proteins, AAV, and bioconjugates. This leader will play an important role in setting the strategic direction for the department, ensuring platform improvements, and driving the integration of emerging technologies. The role serves as a key functional representative, collaborating with Discovery, Manufacturing, and Regulatory to advance programs from preclinical development through successful registration.

Key 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 with minimum 18 years of applicable experience
• Deep knowledge of bioproduct development from candidate selection through regulatory submission
• Excellent communication, interpersonal, and strong leadership skills are essential.
• Demonstrated experience leading high-performance scientific teams

Additional Skills/preferences

• Strong track record of technology innovation in downstream bioprocessing or viral safety
• 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.

Other Information

• Location: Indianapolis
• Travel requirement: less than 10%

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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$156,000 - $228,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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