Associate Director – Biologics Process Engineering, Lilly Medicine Foundry

Lilly Group; Indianapolis (IN); On-site; USD 123,000 - 180,000; Full time

Job summary

Lilly is seeking an Associate Director of Biologics Process Engineering to lead the biologics process engineering organization and ensure reliable, compliant manufacturing of biologics drug substances, including monoclonal antibodies and bioconjugates. The role spans startup to ongoing operations and requires cross-functional collaboration across upstream and downstream units in a GMP environment.

The position emphasizes technical leadership, regulatory alignment, and continuous improvement to

Qualifications

• Bachelor's degree in Engineering, Biochemical Engineering, Chemical Engineering, or related science field.
• 5+ years of experience in a process engineering role supporting biologics drug substance manufacturing or development activities, preferably in a GMP manufacturing environment.
• Demonstrated experience with upstream and/or downstream biologics unit operations (bioreactors, chromatography, filtration, formulation).

Responsibilities

• Lead the biologics process engineering group through recruitment, supervision, coaching, and development planning.
• Provide process engineering work coordination and guidance to key functional groups supporting biologics manufacturing operations (upstream and downstream units).
• Set and reinforce standards for engineering work product and first-principles approach; influence technical agenda and GMP objectives.
• Ensure GMP compliance of facilities, processes, and documentation, maintaining site inspection readiness.

Skills

Leadership

Process engineering

Biologics manufacturing

GMP compliance

Cross-functional collaboration

Regulatory knowledge

Project startup

Change controls

Education

Bachelor's degree in Engineering, Biochemical/Chemical or related science

Tools

SCADA systems

Bioprocess equipment

Single-use technology systems

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.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Associate Director, Biologics Process Engineering provides leadership and direction to the process engineering team to ensure that engineering deliverables are sufficiently resourced and qualified to support biologics drug substance manufacturing and the broader business agenda. This role is responsible for the productivity and development of process engineers with the purpose of ensuring that reliable and compliant equipment and systems are used in the manufacture of biologic products, including monoclonal antibodies, bioconjugates, and other large molecule modalities.

The Biologics Process Engineering Team Leader leads the process engineering organization and influences across functional teams to support the process engineering agenda, business plan priorities, and compliance plan objectives.

In the project delivery and startup phase of the Lilly Medicine Foundry (startup expected 2025 to 2027), leadership roles will be fluid and dynamic as we endeavor to support project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site evolves from a design concept to a GMP clinical trial site.

Key Responsibilities

• Responsible forestablishinga technically advancedbiologicsprocess engineering group. This is achieved through recruitment, supervision, coaching, succession planning, andestablishingactionable development plans, inclusive of completing performance reviews and development planning.
• Provide process engineering work coordination and guidance to key functional groups and partners supporting biologics manufacturing operations, including upstream (cell culture/fermentation) and downstream (purification, filtration, formulation) unit operations.
• In coordination with the engineering function, set and reinforce standards for engineering work product andutilizationof first principles. Partner within Engineering and across functional teams to influence and implement the technical agenda, site business planobjectives, and GMP Quality Planobjectives.
• Ensureappropriate processengineering support forbiologicsoperations including facility fit assessments, process troubleshooting, scale-up/scale-down support, and continuous process improvements for biologic drug substance manufacturing.
• Oversee engineering-related technical issues, improvement initiatives, and technology upgrades specific to biologics unit operations (e.g., bioreactors, chromatography systems, TFF/UF-DF, sterile filtration, single-use systems). Review and approve engineering-related deviations and change controls.
• Ensure GMP compliance of facilities, processes, and documentation,maintainingthe organization in a state ofinspectionreadiness. Ensure all process engineering activities and documentation are performed in alignment with current data integrity requirements.
• Ensure technical review and approval for documents asappropriate, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing records, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, and biologics-specific documents such as process characterization reports and comparability assessments.
• Identify, track, and report key indicators of functional performance.
• Partner appropriately in site planning processes (capital and resource),representingthe interests of the team with a view to the overall site picture and future biologics portfolio.
• Serves as System Owner for designated computer, automation, and bioprocess control systems (e.g., bioreactor SCADA, process chromatography systems).
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits, including BLA/IND-relevant inspections.
• Network globally to share best practices, control strategies, and process rationale to ensure harmonization and alignment between Lilly biologics manufacturing sites.

Startup Phase Responsibilities (2025–2027)

During the startup phase of the Lilly Medicine Foundry, leadership will be expected to be collaborative, inclusive, and support the broader team to:

• Build the biologics process engineering organization with the necessary capability, capacity, and culture tooperatethis facility to the highest standards of operational excellence.
• Develop and implement the systems and processes needed to run the site,leveragingexisting Lilly biologics knowledge and practices where applicable, while also incorporating external experiences and learnings from the broader biopharmaceutical industry.
• Ensure regulatory compliance and operational excellence by supporting lean principles in their respectivearea.
• Support the project team as they deliver the facility to the site team by providing feedback and input on biologics-specific design requirements.

Basic Requirements

• Bachelor's degree in Engineering, Biochemical Engineering, Chemical Engineering, ora relatedscience field.
• 5+ years of experience in a process engineering role supportingbiologicsdrug substance manufacturing or development activities, preferably in a GMP manufacturing environment.
• Demonstrated experience with upstream and/or downstream biologics unit operations (bioreactors, chromatography, filtration, formulation).

Additional Preferences

• Experience leading a team of process engineers highly preferred
• Thorough understanding of bioprocess development and operations, regulatory requirements (FDA, ICH), cGMP, HSE regulations, and data integrity requirements as they apply tobiologicsmanufacturing.
• Experience with single-use technology systems and associated engineering considerations.
• Familiarity withbiologicsregulatory submissions (IND, BLA, CTD modules) and process characterization/validation requirements.
• Capable of collaborating effectively within a team, making autonomous decisions, and influencing a diverse range of groups.
• Skilled at fostering teamwork within the department andshowcasingessential interpersonal skills.
• Proficient in devising creative solutions to plant, divisional, and corporate issues, whileleveraginginsights from various functional areas.
• Experience with cell culture media/feed strategies, viral clearance requirements, andbiologics-specific contamination control strategies is a plus.

Other Information

• Initial location atParkwood West, Indianapolis.
• Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
• Position is standard business hours with flexibility to support activities duringstartup, shutdowns, and weekends asrequired.
• Travel is possible but expected to be minimal.
• Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

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

$123,000 - $180,400

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.

#WeAreLilly