Director- Purification- Process Translation and Execution
Job in
Indianapolis, Marion County, Indiana, 46202, USA
Listed on 2026-08-14
Listing for:
Lilly
Full Time
position Listed on 2026-08-14
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Manufacturing
Job Description & How to Apply Below
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.
** Organization and Function Overview*
* Lilly is investing $4.5 billion in the Lilly Medicine Foundry, a state-of-the-art facility for advanced manufacturing with drug development. The Foundry's mission is to accelerate innovation, expand clinical trial capacity, expedite the delivery of new medicines, and reduce costs and environmental impact.
The Process Translation and Execution (PTE) team drives scientific excellence and innovation to accelerate manufacturing advancements. The team translates DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase-appropriate control strategies, and ensures right-first-time clinical manufacturing for a variety of modalities including synthetic molecules, biologics, peptides, oligonucleotide, and bioconjugates. Through cross-functional collaboration, PTE influences process decisions, revolutionizes clinical manufacturing, building capabilities in emerging technologies and aligning with corporate and LRL goals, and propels the site toward long-term business success.
In the Foundry Construction and Project Delivery/Startup Phase (2026 To 2028), roles will be dynamic as we build a new organization, design lab, develop and implement the necessary systems and business processes required to enable operational readiness, support the project delivery, and build the site culture. Success will require significant collaboration, creativity, and resilience as the Lilly Medicine Foundry transitions from design to startup and ultimately to steady-state operations.
This period presents a unique opportunity for learning, growth, and making a lasting impact.
** Position Summary*
* We're seeking an experienced and passionate technical leader to join the PTE team as a group leader, and help build a culture rooted in collaboration, innovation, and purpose. This role will be instrumental in shaping a high-performing PTE team, driving impactful contributions to pipeline delivery across modalities, and fostering professional growth and development.
** Key Responsibilities*
* ** Team Leadership and Development*
* + Lead, mentor, and develop a team of PTE scientists with deep technical expertise in downstream bioprocessing (chromatography, TFF/UFDF, viral inactivation, and viral filtration) across traditional biologics and mixed modalities (monoclonal antibodies (mAb), antibody-drug conjugates (ADC), antibody-RNA conjugates (ARC), peptides, oligonucleotides).
+ Foster a high-performance environment through regular coaching, one-on-ones, and performance feedback. Promote psychological safety and professional growth.
** Technology Transfer and GMP Production Support*
* + Provide technical oversight for clinical DS purification and conjugation process technology transfers from Process Development to Foundry cGMP operations. Lead/support facility fit assessments, risk analyses, and scale-up strategy to ensure right-first-time execution.
+ Serve as the primary SME on the manufacturing floor, supporting front-line process teams, leading complex deviation investigations and root cause analysis, and driving CAPAs to closure.
+ Collaborate cross-functionally to streamline tech transfer processes, accelerate timelines, and advance digitization of technical documentation and workflows.
+ Ensure Foundry processes remain compliant, capable, and in a qualified state throughout their lifecycle. Support tech transfer for product commercialization.
** Site Technology Strategy and Innovation*
* + Define and lead the Foundry's…
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