Biologics Upstream Scientist - Process Translation and Execution
Eli Lilly and Company
Summary
The scientist will evaluate and facilitate the transfer of biologics manufacturing processes from development laboratories to manufacturing operations, under appropriate supervisory guidance. The scientist will also work in labs to generate data to support tech transfer and troubleshoot operations on the floor, enabling successful transition to early-phase cGMP manufacturing of API required for clinical trial supply.
Job description
Responsibilities
- 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.
- Author, review technical documents, including tech transfer plan, standard operating procedures (SOPs), 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).
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 require 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.
Benefits
- 401(k)
- Pension
- Vacation benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Death benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.