Group Leader, Process Translation & Clinical Manufacturing

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

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.