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Sr. Director - Biologics Purification

Job in Indianapolis, Hamilton County, Indiana, 46262, USA
Listing for: 100 Eli Lilly and Company
Full Time position
Listed on 2026-08-31
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 156000 - 228800 USD Yearly USD 156000.00 228800.00 YEAR
Job Description & How to Apply Below
Location: Indianapolis

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it’s work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview:

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 Summary:

Bioproduct Research and Development (BRD) is seeking a Senior Director to lead the purification 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, 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.

Responsibilities:
  • Leads the purification development department including viral safety 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.
Basic Requirements:
  • Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or related fields, with a minimum of 10 years of pharmaceutical industry experience, or M.S. 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 other biologics CMC areas (i.e., upstream or analytical).
  • Excellent communication, interpersonal, and strong leadership skills are essential.
  • Demonstrated experience leading high-performance scientific teams comprising 10+ employees.
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…
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