Associate - TS/MS Laboratory-Downstream
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 39,000 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.
The TS/MS Laboratory in Branchburg supports commercial and late stage clinical manufacturing through the development and use of comprehensive small scale models, both upstream and downstream. Our vision is to support the smooth, timely and efficient transfer of new molecules in and out of the site with facility fit and cGMP compliance in mind, as well as to support commercially manufactured products. We are committed to streamlining manufacturing through creative experimental design and an in-depth knowledge of the relevant molecules and processes. This is a laboratory-based position and requires approximately 70% of hands-on laboratory work, with the remainder including experimental design, data analysis and report preparation
We are looking for a talented downstream scientist/engineer to join the TS/MS lab, who will be responsible for designing, planning, executing and troubleshooting of laboratory experiments in support of manufacturing operations, continuous improvement, process validation and technology transfer. The candidate should have previous experience in downstream chromatography and filtration techniques. Prior experience in analytical methods is preferred, and would be cross-trained to understand and perform such methods related to TS/MS projects.
Process Support, Process Improvement, and Technology Transfer
- Understand the purpose and science of the recombinant biologic production & purification process; have an in-depth knowledge of the science (including analytical) behind the molecule and the process.
- Transfer from R&D and qualify downstream purification laboratory models for late stage clinical and commercial manufacturing processes.
- Perform laboratory experiments in scale-down models designed to further understand and improve the process. Work with Manufacturing to resolve technical issues / deviations and implement corrective / preventative actions in the plant.
- Work with R&D and Manufacturing to develop, transfer and implement well-understood, robust and fit-for-purpose process control strategies.
- Document studies in electronic lab notebook (ELN), author reports based on laboratory studies and communicate/transfer relevant information and data.
- Understand, and perform all job responsibilities in compliance with, safety and regulatory expectations.
- B.S./M.S. in Bio/Chemical Engineering, Bio/chemistry, Biology or related science, a minimum of 5 years of experience in a cGMP biopharmaceutical manufacturing and/or development environment.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
- Experience/understanding of filtration and chromatography techniques used in the manufacturing of recombinantly expressed therapeutics.
- Experience setting up methods, operating and troubleshooting the Akta chromatography system.
- Experience with using JMP software for data analysis and knowledge of design of experiment (DoE) principles.
- The ideal candidate would gain the process understanding to later rotate into a front-line TS/MS process support role in the manufacturing plant.
- Experience/understanding of recombinant monoclonal antibody analytical methods, including HPLC experience.
- Have prior understanding of cGMP and regulatory requirements
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.