Overview:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader, headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development, Lebanon, Indiana. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

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 Scientist will be responsible with facilitating the transfer of chemical processes for bioconjugation process' to produce ADCs and similar modalities, from development laboratories to pilot plant operations (including kilo-scale and production environments), operating independently and guiding more junior scientists. This enables the successful transition to early-phase cGMP manufacturing of grams to kilogram quantities of API required for clinical trial supply.

• Experience performing bioconjugation chemistry to form ADC's including antibody preparation, buffer exchanges and protein specific characterization (DAR analysis, aggregate assessment...).
• Hands-on experience across multiple conjugation strategies (maleimide, click, enzymatic).
• Experience working with highly potent molecules and containment in the lab and production environments as well as working with single-use bioprocessing systems.
• Ability to mentor less experienced scientists and ultimately supervise colleagues.
• Ability to work cross-functionally across disciplines and levels with engineers, analytical chemists, chemical technicians, safety and quality representatives.
• Actively involved in receiving chemistry from early phase process research and development labs and evaluating the safety of the incoming procedures in collaboration with the safety group and process engineering.
• Ensure raw material and reagent readiness, obtain reference materials, and participate in setting up analytical methods.
• 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 reactions to ensure plant readiness of process steps including reduction/conjugation/oxidation reactions and Tangential Flow Filtration (TFF) operations at the Lilly Medicine Foundry.
• Perform use-tests of key raw 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 chemistry, 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 with 6+ years of experience or PhD with 2+ years of experience in manufacturing environments involving biochemistry, chemical biology, conjugation chemistry, chemical engineering or related field.

Additional Preferences:

• Working knowledge of organic chemistry and mechanisms and application to reaction improvement and optimization.
• Knowledge of and hands-on experience with analytical methods used for small molecules and biomolecules (RP-HPLC, SEC, IEX, HIC, LC-MS, CE-SDS).
• Hands-on experience with liquid chromatography: bioconjugate purification and familiarity with chromatography systems.
• Experience with synthetic chemistry techniques used for developing and scaling-up chemical reactions. Experience using process chemistry concepts is a plus.
• Comfortable working with larger sized glass equipment as well as single use equipment.
• Demonstrated ability to independently lead a technology transfer end to end, from development lab to clinical manufacturing.
• Has experience creating batch records and conducting scale-up experiments according to those records.
• Ability to prioritize multiple activities and manage ambiguity.
• 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
• 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

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$129,000 - $209,000

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.

#WeAreLilly