Mixed Modality (Oligonucleotide) Scientist

Lilly • Indianapolis, IN

2d • $67,500 - $173,800

About The Position

Lilly is hiring a scientist for its Process Translation and Execution (PTE) team supporting the Lilly Medicine Foundry, a new advanced manufacturing and drug development center in Lebanon, Indiana. PTE translates API and drug substance process knowledge into clinical supply readiness, oversees technology transfer, implements phase-appropriate control strategies, and supports right-first-time clinical manufacturing across multiple modalities.

The role focuses on evaluating and facilitating the transfer of oligonucleotide manufacturing processes from development laboratories to pilot plant operations, including kilo-scale and isolator production environments. The scientist will help transition processes to early-phase cGMP manufacturing of gram-to-kilogram quantities of API for clinical trials. Responsibilities span process assessment and scale-up, plant-readiness activities, technical documentation, troubleshooting, process improvement, investigations, and collaboration with cross-functional teams. The position includes support for the Foundry’s construction, project delivery, and startup phase, when roles and systems will evolve as the site moves toward operational readiness and steady-state operations.

The initial work location is Lilly Technology Center in Indianapolis and/or Parkwood West; the permanent location is the Lilly Medicine Foundry in Lebanon, Indiana. The role requires work in manufacturing and laboratory environments, and limited domestic and international travel of less than 5% may be required.

Requirements

• Bachelor’s or master’s degree in Chemistry, Biochemistry, Chemical or Biochemical Engineering, or a related discipline.
• With a bachelor’s degree, 10 or more years of experience in oligonucleotide product or process development, manufacturing technical services, or a related functional role; with a master’s degree, 7 or more years of such experience.
• Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor or support work authorization or visas for this role.
• Ability to work in manufacturing and laboratory environments.
• Ability to prioritize multiple activities and manage ambiguity.
• Strong attention to detail and ability to learn rapidly.

Nice To Haves

• Strong knowledge of oligonucleotide upstream or downstream processes, including synthesis, cleavage and deprotection, chromatography, conjugation, and aseptic processing.
• Ability to analyze data, perform root-cause analysis, and resolve complex technical challenges; understanding of biopharmaceutical manufacturing principles and cGMP requirements.
• Demonstrated success in cross-functional, dynamic, and matrixed environments.
• Excellent written and verbal communication skills for technical reports, presentations, and collaboration.
• Experience leading small projects, coordinating activities, and managing timelines; supervisory experience with junior scientists or technicians is highly preferred.
• Proactive engagement with external innovation and industry trends, with ability to champion adoption of transformative manufacturing technologies.
• Experience with oligonucleotide synthesis and purification techniques used to develop and scale-up process reactions; process chemistry experience is a plus.
• Comfort working with larger reactors, preparative columns, TFF, and related equipment.
• Experience creating batch records and conducting scale-up experiments according to those records.
• Experience with analytical techniques such as HPLC/UPLC, LC-MS, and GC.
• Experience with process quantification and mass-balance acquisition for products and by-products.

Responsibilities

• Evaluate and facilitate transfer of oligonucleotide manufacturing processes from development laboratories to pilot plant operations, including kilo-scale and isolator production environments.
• Oversee transfer of new oligonucleotide processes from development to manufacturing and ensure scalability and fit to the plant.
• Assess and scale up synthesis and purification methods from early-phase process research and development laboratories.
• Perform and support oligonucleotide procedures including solid-phase synthesis, preparative chromatography, TFF, and lyophilization.
• Evaluate the safety of incoming procedures in collaboration with the safety group and process engineering.
• Analyze analytical data to make fact-based decisions and summarize and present chemistry and process challenges.
• Lead familiarization executions at the Lilly Medicine Foundry to ensure plant readiness for synthesis, cleavage, purification, TFF, and lyophilization steps.
• Perform use-tests of key in-process materials and document Definitive Lab Trials to confirm plant readiness.
• Author and review technical documents, including technology transfer plans, SOPs, batch records, campaign summary reports, and deviation reports.
• Identify process improvements and implement new technologies or procedures.
• Lead process-related investigations, assess deviations, and support CAPAs.
• Collaborate with CMC, Product R&D, Manufacturing, and Quality teams.
• Provide on-floor support for critical operations and train or mentor junior scientists and technicians in PTE activities.

Benefits

• 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, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

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