Bioprocess Scientist - Process Translation and Execution Lilly Medicine Foundry

Eli Lilly and Company • Lebanon, IN

2d

About The Position

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 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 bioprocess scientists to join the PTE team and help bring the Lilly Medicine Foundry’s vision to life.

Requirements

• B.S. or M.S. in biological sciences, chemical engineering, or related field.
• 2+ years of experience in manufacturing environments involving large molecule API or drug substance is preferred.

Nice To Haves

• Working knowledge of mammalian cell culture, primary recovery and purification unit operations and process optimization.
• Experience supporting multiple therapeutic modalities in addition to monoclonal antibodies, for example, antibody drug conjugate-related operations.
• Experience with development and scale-up of cell culture and purification process steps.
• Comfortable working with larger sized bioreactors and downstream-related equipment in a cGMP regulated production environment.
• Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
• Experience creating batch records and process execution according to those records.
• Ability to prioritize multiple activities and manage ambiguity.
• Experience with analyzing data from a variety of analytical techniques, for example, HPLC/UPLC, SEC, CEX, CE-SDS, LC-MS, etc.
• 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 operations, process engineers, analytical chemists, safety and quality representatives.

Responsibilities

• Facilitating the transfer of biological processes, under appropriate supervisory guidance, from development laboratories to production operations.
• Actively involved in receiving process information from research and development labs and translating that into execution at production scale in collaboration with operations, process engineering, quality and health and safety groups.
• Ordering and staging raw materials.
• Collaborate in setting up analytical methods and analyzing analytical data to make fact-based decisions.
• Efficient with summarizing and presenting process results and challenges.
• Perform scale-down studies to ensure plant readiness and support evaluation of new technology at small-scale for process steps including upstream cell culture and downstream purification operations at the Lilly Medicine Foundry.
• Evaluate key raw materials to support process transfer and execution and confirm plant readiness.
• Maintain accurate lab notebooks with accurate descriptions of process steps, observations and results to support technical transfers into the production environment.
• Author, review technical documents, including the process transfer plan, batch records, campaign summary reports, and deviation reports.
• 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).

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees