Sr Director Process Translation

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

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 API/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 (ADC,ARC etc.). Through cross-functional collaboration, PTE influences commercial 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 (2025 To 2028), roles will be fluid and 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

• Guide, mentor, and supervise a team of PTE scientists and engineers, provide technical expertise and guidance throughout all project phases.
• Provide regular coaching and support to team members to enhance their skills and achieve their professional growth goals; foster a high-performance, positive, and productive work environment.
• Conduct regular one-on-one meetings and performance reviews to provide constructive feedback and elevate team performance.
• Promote psychological safety, create an environment where team members feel safe to take calculated risks and learn from failures.

Streamlined Technology Transfer

• Provide strategic leadership and oversight for clinical API or DS technology transfer activities from Process Development to Foundry cGMP Operations; leverage deep process understanding to guide successful tech transfer, ensure right-first-time execution and reliable clinical supply.
• Drive timely development, review, and alignment of critical technical documentation required for tech transfer. Lead and support facility fit assessments, risk analyses to proactively identify and mitigate scale-up and manufacturing risks.
• Collaborate actively with cross-functional teams to shape and implement robust tech transfer strategies. Identify opportunities to accelerate timelines and streamline processes for continuous improvement, while influencing key process decisions that impact Foundry deliverables for clinical manufacturing.

Molecule/Process Stewardship, Manufacturing Support

• Serve as the primary Subject Matter Expert (SME) for clinical API manufacturing processes, providing scientific and technical support to front line process teams and operations on the manufacturing floor.
• Lead or support complex deviation investigations (including lab studies), root cause analysis, and the implementation of Corrective and Preventive Actions (CAPAs).
• Collaborate closely with Process Development and Engineering teams to identify and implement process enhancements and optimizations. Support tech transfer for product commercialization.
• Ensure all Foundry processes remain compliant, capable, and in a qualified state throughout their development lifecycle.

Site Technology Strategy and Innovation

• Guide design and CAPEX initiatives to ensure PTE lab capabilities are continuously aligned with the evolving demands of the clinical portfolio.
• Define and lead Foundry's technical strategy, identifying and implementing next-generation capabilities to support new clinical assets and evolving portfolio needs.
• Champion and evaluate emerging technologies, I,e including continuous flow chemistry, advanced bioprocessing, automation, Process Analytical Technology (PAT), and advanced process control strategies.
• Collaborate with Global TSMS, Process Development, Process Engineering teams to scout, assess, and industrialize innovations that enhance process robustness, efficiency, and sustainability.

Cross-Functional Collaboration and External Interface

• Act as a key technical liaison and project leader for cross-functional teams, including Process Development, Engineering, Analytical, Quality, Supply Chain and Raw Materials, and Regulatory Affairs.
• Represent the PTE team during regulatory inspections / audits, serving as a knowledgeable and credible SME.
• Build and maintain effective relationships with external partners, lead external collaborations to advance site tech agenda and innovation initiatives.

Basic Qualifications

Education

• PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines.
• 12+ years of industry experience in API/DS manufacturing technical services, TSMS/MSAT, API/ DS process development, or related functions.
• Demonstrated technical expertise and leadership in process innovation, with experience influencing cross-functional partners and implementing new processes.
• Extensive experience in leading, coaching, and developing direct reports, fostering a culture of growth and accountability.
• Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements related to pharmaceutical API/DS manufacturing and tech transfer.

Additional Skills and Preferences

• Excellent written and verbal communication.
• Effective interpersonal and communication skills; strong conflict-resolution skills and experience in building cohesive teams.
• A servant-leader mindset, focused on empowering the team and removing obstacles.

Additional Information

• Initial location: Lilly Technology Center, Indianapolis.
• 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 ) 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$151,500 - $222,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and 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.