Chemist - Process Translation and Execution Lilly Medicine Foundry

Location: Indianapolis

Chemist - Process Translation and Execution Lilly Medicine Foundry page is loaded## Chemist - Process Translation and Execution Lilly Medicine Foundry locations: US, Lebanon IN: US:
Indianapolis IN Tech Center Northtime type:
Full time posted on:
Posted Todayjob requisition : R-98025

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.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. 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  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 Chemist will be responsible with facilitating the transfer of chemical processes, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilohood or larger-scale production). This enables the successful transition to early-phase cGMP manufacturing of kilogram quantities of API required for clinical trial supply.
* 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.
* 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 results and challenges.
* Perform familiarization reactions to ensure plant readiness of process steps including chemical reactions, distillations, extractions, and crystallization/isolations 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.
* 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.
* 2+ years of experience in manufacturing environments involving synthetic small molecule API or drug substance, or fine chemical synthesis is…