Mixed Modality (Peptide Downstream) Scientist - Process Translation and Execution

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.

About the role

The Process Translation and Execution (PTE) 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 process design, revolutionizes clinical manufacturing, builds capabilities in emerging technologies, and aligns with corporate and Lilly Research Labs (LRL) goals.

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 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 and continuous improvement. This period presents a unique opportunity for learning, growth, and making a lasting impact.

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

Responsibilities

• Evaluate and facilitate the transfer of peptide downstream manufacturing processes, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale and isolator production environments) to enable the successful transition to early-phase cGMP manufacturing of grams to kilogram quantities of API required for clinical trial supply.
• Perform peptide purification and isolation and assess purification methods from early phase process research and development labs.
• Demonstrate familiarity with performing peptide downstream procedures, such as reverse-phase chromatography, TFF, lyophilization, and precipitation & drying.
• Evaluate the safety of the incoming procedures in collaboration with the safety group and process engineering.
• Order and stage chemicals, obtain reference materials, and participate in setting up analytical methods.
• Reprocess and analyze analytical data to make fact-based decisions.
• Summarize and present chemistry and challenges efficiently.
• Perform familiarization executions to ensure plant readiness of process steps including chemical reactions, purification, TFF, lyophilization, and precipitation & drying at the Lilly Medicine Foundry.
• Perform use-tests of key in-process materials and document Definitive Lab Trials of processes to confirm plant readiness.
• Maintain a well-organized and detailed lab notebook with accurate descriptions of the procedures, observations, and organized analytical data to enable the preparation of technical packages/technical transfers and accurate replication in receiving labs.
• Author and review technical documents, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.
• Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.
• Contribute to process troubleshooting and investigations by supporting process deviations, quality events, and non-conformances.
• Collaborate with teams to perform root cause analysis (RCA) and develop effective corrective and preventive actions (CAPAs).

Requirements

• B.S. or M.S. in chemistry, chemical engineering, or related field.
• 3+ years of experience in synthesis peptide purification and/or manufacturing environments involving synthetic peptide API or drug substance.
• Experience with reverse-phase chromatography is preferred.
• 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Skills

• Working knowledge of peptide downstream chemistry and purification and application towards improvement and optimization.
• Experience with peptide purification techniques used for developing and scaling-up chemical reactions.
• Experience using process chemistry concepts is a plus.
• Proficiency with peptide purification via chromatography and TFF and downstream conjugation and cyclization.
• Comfortable working with larger sized 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 a variety of analytical techniques: HPLC/UPLC, LC-MS, GC, NMR, etc.
• Process quantification and acquiring mass balance for products and by-products.
• Demonstrated ability to drive projects and accept change.
• Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
• Familiarity with peptide upstream synthesis and cleavage and understanding of precipitation and safe handling of solids/dry end processing.
• Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
• Ability to work cross-functionally across disciplines and levels with engineers, analytical chemists, chemical technicians, safety and quality representatives.

Benefits

• Eligibility to participate in a company-sponsored 401(k) and 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $66,000 - $171,600. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).