Biologics Upstream Scientist - Process Translation and Execution

Lilly • Indianapolis, IN

22h • $67,500 - $173,800 • Onsite

About The Position

The Biologics Upstream Scientist will join Lilly’s Process Translation and Execution (PTE) team, which translates API and drug-substance process knowledge into clinical supply readiness and supports technology transfer, phase-appropriate control strategies, and right-first-time clinical manufacturing across multiple modalities. The role supports the development of the Lilly Medicine Foundry in Lebanon, Indiana, a new center combining research and manufacturing. During the Foundry’s construction, project delivery, and startup phase (2025–2028), responsibilities and organizational needs will evolve as the site moves from design to startup and steady-state operations.

Under appropriate supervisory guidance, the scientist evaluates and facilitates transfer of biologics manufacturing processes from development laboratories to manufacturing operations. The work combines laboratory studies and data generation with support for manufacturing-floor execution and troubleshooting, helping enable early-phase cGMP API manufacturing for clinical trial supply. The scientist collaborates with operations, process engineering, quality, and other teams to prepare processes for execution at production scale.

The position requires onsite work and may initially be based at Lilly Technology Center-North in Indianapolis and/or Parkwood West in Carmel, with a permanent location at the Lilly Medicine Foundry in Lebanon, Indiana. Limited domestic and international travel of less than 5% may be required. The anticipated wage range is $67,500–$173,800. Full-time employees may be eligible for a company bonus and a comprehensive benefits program, subject to applicable eligibility and plan terms.

Requirements

• Bachelor’s or master’s degree in Chemical or Biochemical Engineering, Biochemistry, Biological Engineering, or a related discipline.
• At least 5 years of experience in biologics upstream and/or API manufacturing environments.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.
• Able to work onsite and in manufacturing and laboratory environments.

Nice To Haves

• Working knowledge of biologics downstream processing, including improvement and optimization.
• Comfort working in a large-scale bioreactor and related-equipment environment.
• Working knowledge of upstream process analytical technology, including biocapacitance probes, Raman probes, and other real-time monitoring used for process decisions.
• Experience with single-use upstream and downstream systems, such as single-use bioreactors, chromatography skids, single-use mixing systems, and single-use tangential flow filtration; familiarity with advanced platforms such as PCC or continuous chromatography.
• Experience creating batch records and conducting scale-up experiments according to those records.
• Experience with analytical techniques such as HPLC/UPLC, SEC, CEX, and CE-SDS.
• Experience quantifying processes and obtaining product and by-product mass balances.
• Demonstrated ability to drive projects and adapt to change.
• Excellent written and verbal communication for technical reports, presentations, and cross-team collaboration, including strong conflict-resolution skills.
• Ability to analyze data, perform root-cause analysis, and resolve complex technical challenges.
• Ability to prioritize multiple activities and manage ambiguity.
• High motivation, rapid learning ability, and strong attention to detail.

Responsibilities

• Receive process information from research and development laboratories and translate it into production-scale execution in collaboration with operations, process engineering, and quality; order and stage raw materials.
• Work with biologics upstream unit operations, including shake-flask expansion, N-3/N-2/N-1 processing, N bioreactor production with and without perfusion, and primary recovery.
• Perform scale-down and scale-up studies to support plant readiness, evaluate new technologies at small scale, and assess key raw materials for process transfer and execution.
• Conduct familiarization executions and definitive laboratory trials to ensure process-step readiness for the plant.
• Obtain reference materials, participate in establishing analytical methods, and process and analyze analytical data to support fact-based decisions.
• Summarize and present data and challenges efficiently.
• Maintain a well-organized, detailed electronic laboratory notebook documenting procedures, observations, and analytical data to support technical packages, technology transfers, and accurate replication in receiving laboratories.
• Author and review technical documents, including technology-transfer plans, standard operating procedures, batch records, campaign summary reports, and deviation reports.
• Apply scientific knowledge to identify process improvements and implement new technologies or procedures.
• Support process troubleshooting and investigations involving deviations, quality events, and non-conformances; collaborate on root-cause analysis and corrective and preventive actions.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation, subject to eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits, subject to eligibility.
• Flexible benefits, such as healthcare and dependent day-care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level