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, drives scientific excellence and innovation to accelerate manufacturing advancements and propels the site toward long-term business success.
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.
We are seeking passionate and agile chemists to join the PTE team and help bring the Lilly Medicine Foundry’s vision to life.
Responsibilities
In this role, the Mixed Modality (Peptide Downstream) Scientist will be responsible with evaluating and facilitating 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). This enables 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
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.
Ordering and staging chemicals.
Obtain reference materials and participate in setting up analytical methods.
Reprocess and analyze analytical data to make fact-based decisions.
Efficient with summarizing and presenting chemistry and challenges.
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.
Documentation: Author, review technical documents, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.
Process improvement: 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)
Basic 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. Reverse-phase chromatograph 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
Additional Preferences
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.
Has 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.
Communication skills: 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.
Problem-solving skills: 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.
Other Information
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
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.
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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
- $66,000 - $171,600
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.
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