Director- Purification- Process Translation and Execution

Biopharma Careers; Lebanon (KY); On-site; USD 152,000 - 264,000; Full time

Benefits offered by this job

401(k) plan

Pension

Job summary

Lilly announces a Group Leader for the Process Translation and Execution (PTE) team in Lebanon, IN, with initial location in Indianapolis, IN. The role drives collaboration, innovation, and high performance to advance purification strategies and tech transfer for diverse biologics across modalities.

The position emphasizes mentorship, cross-functional influence, and a focus on right‑first‑time clinical manufacturing, CAPA closure, and digitization of technical documentation in a cGMP framework.

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 processes.
• Deep expertise in downstream unit operations including chromatography, TFF/UFDF, viral inactivation, and viral filtration.
• Experience leading, coaching, and developing direct reports, fostering growth and accountability.

Responsibilities

• Lead, mentor, and develop a team of PTE scientists with deep technical expertise in downstream bioprocessing across modalities.
• Provide technical oversight for clinical DS purification and conjugation process 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.
• 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.

Skills

Biologics DS leadership

Team leadership

Process transfer

Regulatory compliance

Education

PhD in Biology or related

Tools

Chromatography systems

TFF/UFDF

cGMP documentation tools

Job description

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.

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.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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