Biologics Upstream Scientist

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.

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 scientists 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 evaluating and facilitating the transfer of biologics manufacturing processes, under appropriate supervisory guidance, from development laboratories to manufacturing operations. Additionally, the scientist will also be able to work in labs to generate data to support the tech transfer and troubleshooting the operations on the floor. This enables the successful transition to early-phase cGMP manufacturing of API required for clinical trial supply.

• Receive process information from research and development labs, translate that into execution at production scale in collaboration with operations, process engineering, and quality, and order and stage raw materials.

• Familiar with biologics upstream unit operations, such as shake flask expansion, N-3/2/1 process, N bioreactor production, with and without perfusion, and primary recovery.

• Working knowledge of downstream process (with antibody conjugate-related process as a plus).

• Perform scale-down and scale-up studies to ensure plant readiness and support evaluation of new technology at small-scale for process steps and evaluate key raw materials to support process transfer and execution.

• Perform familiarization executions and definitive lab trial to ensure plant readiness of process steps.

• Obtain reference materials and participate in setting up analytical methods; process and analyze analytical data to make fact-based decisions.

• Efficient with summarizing and presenting data and challenges.

• Maintain a well-organized and detailed (electronic) lab notebook with accurate descriptions of the procedures, 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 Chemical/Biochemical Engineering, Biochemistry, Biological Engineering, or related disciplines.

• 5+ years of experience in biologics upstream and/or manufacturing API environments

• Role will requirement onsite presence

• 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 biologics downstream towards improvement and optimization.

• Comfortable working with large scale bioreactor and related-equipment environment.

• Working knowledge of process analytical technology (PAT) for upstream operations, including biocapacitance probe, Raman probe, and other real-time monitoring for process decisions.

• Experience with single-use upstream (single-use bioreactors) and downstream processing systems (e.g., SU chromatography skids, SUMs, SU TFF) and familiarity with advanced and innovative platforms such as PCC/continuous chromatography.

• Has experience creating batch records and conducting scale-up experiments according to those records.

• Experience with a variety of analytical techniques: HPLC/UPLC, SEC, CEX, and CE-SDS, 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; strong conflict-resolution skills.

• Problem-solving skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.

• Ability to prioritize multiple activities and manage ambiguity.

• Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.

Other Information:

• Initial location at Lilly Technology Center-North, Indianapolis and/or Parkwood West (Carmel, IN)

• 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.#WeAreLilly

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 $67,500 - $173,800

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