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 Upstream) advisor will be responsible with synthetically evaluating and facilitating the transfer of peptide upstream 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.
Oversee the successful transfer of new peptide 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 peptide synthetic routes from early phase process research and development labs
Familiarity with performing peptide upstream procedures, such as SPPS and Cleavage & Precipitation.
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.
Lead familiarization executions to ensure plant readiness of process steps including SPPS and Cleavage & Precipitation at the Lilly Medicine Foundry.
Perform use-tests of key raw materials and document Definitive Lab Trials of processes to confirm plant readiness. · 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.
Lead 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., M.S., or Ph.D. in chemistry, chemical engineering, or related field.
B.S. with 8+ years, M.S. with 5+ years, or Ph.D. with 2+ years of experience in peptide chemistry and/or manufacturing environments involving synthetic peptide API or drug substance. Solid phase peptide synthesis is preferred.
Additional Preferences
Strong knowledge of peptide chemistry and mechanisms and application to reaction improvement and optimization.
Experience with synthetic chemistry techniques used for developing and scaling-up chemical reactions. Experience using process chemistry concepts is a plus.
Proficiency with the synthesis of peptide crude via solid phase peptide synthesis and cleavage & deprotection.
Comfortable working with larger sized 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 downstream purification, TFF, lyophilization 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.
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 dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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
- $130,500 - $211,200
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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