Mixed Modality (Oligonucleotide) Scientist

Position Overview

The Mixed Modality (Oligonucleotide) Principal Scientist will evaluate and facilitate the transfer of oligonucleotide manufacturing processes, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale and isolator production environments). This enables the successful transition to early-phase cGMP manufacturing of grams to kilogram quantities of API required for clinical trial supply.

Responsibilities

• Oversee the successful transfer of new oligonucleotide processes from development to manufacturing; ensure scalability and process fit to plant; apply scientific knowledge to troubleshoot production issues and implement new technologies or procedures.
• Assess and scale-up synthesis and purification methods from early phase process research and development labs.
• Perform oligonucleotide procedures such as 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; summarize and present chemistry and challenges.
• Lead familiarization executions to ensure plant readiness of process steps including synthesis, cleavage, purification, TFF, and lyophilization at the Lilly Medicine Foundry.
• Perform use-tests of key in-process materials and document Definitive Lab Trials of processes to confirm plant readiness.
• Author and review technical documents including tech transfer plans, SOPs, batch records, campaign summary reports, and deviation reports.
• Apply scientific knowledge to identify areas for improvement 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/mentor junior scientists and technicians.

Basic Requirements

• B.S. or M.S. in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or a related discipline.
• B.S. with 10+ years or M.S. with 7+ years of experience in Oligonucleotide Product/Process Development, Manufacturing Technical Services, or related functional roles.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

Additional Preferences

• Strong knowledge of oligonucleotide process (upstream or downstream), including synthesis, cleavage & deprotection, chromatography, conjugation, and aseptic processing.
• Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges; solid understanding of biopharmaceutical manufacturing principles and cGMP requirements.
• Demonstrated success in cross-functional, dynamic, and matrixed environments; excellent written and verbal communication skills.
• Previous experience leading small projects, coordinating activities, and managing timelines; supervisory experience of junior scientists or technicians highly preferred.
• Proactive engagement with external innovation and industry trends.
• Experience with oligo synthesis and purification techniques used for developing and scaling-up process reactions.
• Experience using process chemistry concepts is a plus.
• Comfortable working with larger sized reactors and preparative columns, TFF, and related equipment.
• Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
• Experience creating batch records and conducting scale-up experiments according to those records.
• Ability to prioritize multiple activities and manage ambiguity.
• Experience with analytical techniques: HPLC/UPLC, LC-MS, GC, etc.
• Process quantification and acquiring mass balance for products and by-products.

Other Information

Initial location at Lilly Technology Center, Indianapolis and/or Parkwood West. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Limited domestic and international travel (< 5%) may be required. Role requires ability to work in manufacturing and laboratory environments.