Sr. Director-Purification and Viral Safety
Listed on 2026-07-09
-
Business
Regulatory Compliance Specialist
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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Organization And Position SummaryBioproduct 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 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.
- Lead the purification development and viral safety department to enable development, scale‑up, and technology transfer for both early‑ and late‑stage bioproduct portfolios.
- Establish and drive the strategic direction of the department, ensuring strong execution to support portfolio growth and meet organizational objectives.
- Provide oversight to ensure the department stays current with emerging technologies, capabilities, and evolving regulatory initiatives, and lead their effective implementation.
- Define and drive innovation strategy and roadmap to ensure competitiveness and alignment with Discovery and manufacturing needs.
- Proactively reallocate resources to respond to changing portfolio demands, including program acceleration, while driving productivity through operational excellence.
- Lead the adoption and integration of AI/ML tools, process modeling, and high‑throughput screening to advance purification and viral safety workflows.
- Develop talent at all levels and ensure effective coaching and performance management.
- Oversee development laboratory operations, including the scale‑up facility, with a strong focus on workplace safety.
- Collaborate closely with leaders across departments to ensure overall business effectiveness.
- 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.
- 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.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).