Clinical Trial Startup Jobs in Indiana (NOW HIRING)

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. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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 uid 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 seekingpassionate 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 ADC's and similar modalities, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale and production environments). 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...).
• 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.
• Experience working with highly potent molecules and containment in the lab and production environments as well as working with single-use bioprocessing systems.
• 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 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 3+ years of experience in manufacturing environments involving biochemistry, chemical biology , conjugation chemistry, chemical engineering or related field.
• 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 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.
• 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.
• 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

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

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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