Director - Process Translation and Execution (Purification)

Construction Association of Michigan; Indianapolis (IN); On-site; USD 190,000 - 260,000; Full time

Job summary

Lilly Medicines Foundry in Lebanon, Indiana seeks an experienced technical leader to join the PTE team as a group leader, shaping a high-performing group and delivering pipeline support across modalities. You will mentor scientists, oversee tech transfer, and drive right-first-time manufacturing excellence in a growing organization.

The role requires a PhD with 12+ years in biologics DS development or manufacturing, plus hands-on expertise in downstream operations and regulatory interactions.

Qualifications

• PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines.
• 12+ years of industry experience in biologics DS development or manufacturing, with 8+ years in purification.
• Deep expertise in downstream unit operations including chromatography, TFF/UFDF, viral inactivation, and viral filtration.
• Experience with column packing, resin lifetime management, and scale-up strategies.
• Experience in leading, coaching, and developing direct reports.

Responsibilities

• Lead, mentor, and develop a team of PTE scientists with deep technical expertise in downstream bioprocessing.
• Provide technical oversight for clinical DS purification and conjugation process tech transfers to cGMP ops.
• Lead deviation investigations, root cause analysis, and CAPA closure on the manufacturing floor.
• Collaborate cross-functionally to streamline tech transfer and digitize workflows.
• Define and lead purification and conjugation technology strategy, and support CAPEX initiatives.
• Represent PTE in regulatory inspections and audits as a credible SME.

Skills

Team leadership

Downstream bioprocessing

Chromatography

TFF/UFDF

Viral inactivation

Viral filtration

Process transfer

CAPA

Regulatory inspections

Project leadership

Education

PhD in Biology/Biochemistry/Biological Engineering/Chemical Engineering

Tools

Single-use downstream systems (e.g., skids, SUMs)

PCC/continuous chromatography

Process Analytical Technology (PAT)

Job description

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 purification and conjugation technology strategy, assessing, and industrializing next-generation capabilities in partnership with Process Development, Process Engineering, and Global TSMS.
• Guide/support CAPEX initiatives to keep PTE and Foundry capabilities aligned with evolving portfolio demands.

Cross-Functional Collaboration and Influence

• Act as a key technical liaison across Process Development, Process Engineering, Analytical, Quality, Supply Chain, HSE and Operations.
• Represent PTE during regulatory inspections and audits as a credible technical SME.
• Build and maintain external partnerships to advance the site's technology and innovation agenda.

Basic Qualifications

• PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines.
• 12+ years of industry experience in biologics DS development or manufacturing, with 8+ years of direct experience in purification processes.
• Deep expertise in downstream unit operations including chromatography (affinity, ion exchange, mixed-mode), tangential flow filtration (TFF/UFDF), viral inactivation (low pH, detergent), and viral filtration.
• Experience with column packing, resin lifetime management, and scaling strategies from bench to clinical manufacturing scale.
• Extensive experience in leading, coaching, and developing direct reports, fostering a culture of growth and accountability.

Additional Skills and Preferences

• Hands-on experience with bioconjugation processes such as antibody-drug conjugates (ADC), antibody-RNA conjugates (ARC), or related conjugation processes. Familiarity with conjugation reaction optimization, DAR control, and post-conjugation purification including organic solvent handling at moderate scale.
• Experience with single-use downstream processing systems (e.g., single-use chromatography skids, SUMs, single-use TFF) and familiarity with platforms such as PCC/continuous chromatography.
• Working knowledge of process analytical technology (PAT) for downstream operations, including inline UV, conductivity, and pressure monitoring for real-time process decisions.
• Leadership in process innovation and continuous improvement, including complex deviation investigations, root cause analysis, and CAPA implementation.
• Familiarity with emerging purification modalities relevant to next-generation biologics (e.g., mRNA purification, LNP downstream processing, or novel affinity ligands).
• Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements related to pharmaceutical API/DS manufacturing and tech transfer.
• Effective interpersonal and communication skills; strong conflict-resolution skills and experience in building cohesive teams.

Additional Information

• Initial location: Indianapolis, IN
• Permanent location: Lilly Medicines Foundry, Lebanon, Indiana.
• Limited domestic and international travel (5-10%) required.
• Ability to work in manufacturing and laboratory environments.