Elanco is seeking a PhD level technical leader in the Pharmaceutical, Vaccine, Science and Technology (PVS&T) group for Large Molecule Process Development (Vaccines, Biotherapeutics and Nutritionals). The primary responsibility of this role will be to set the fermentation strategy in order to drive and continuously improve upon the existing/new processes and to fully characterize Elanco's early and late phase Large Molecule fermentation product related portfolio. The Fermentation scientist will lead and directly work with a team of scientists and technical staff. The ideal candidate will provide technical coaching as well as hands-on training, in-the-lab technical leadership, and assist in all of PVS&T's fermentation network. This position will work closely with the Downstream, Formulations and Analytical scientists to support the advancement of the portfolio as well as to drive new innovations and platform capabilities. They will drive a culture of innovation driven by a strong knowledge of fermentation science. Additional core responsibilities include:
Ensuring completeness and technical quality of the research work to ensure integrity of data generated in the laboratory.
Supporting regulatory and quality initiatives and working collaboratively with and advice internal Elanco business partners.
Background in statistics: DOE designs and data analysis. Implementation of computer and lab scale modeling for the team.
Setting scale up/manufacturing process strategy and identifying and evolving Elanco's future capabilities.
This role primarily supports development mode activities but they may also help to build and maintain some GMP capabilities and support manufacturing when required.
The ability to independently execute experiments, coupled with a "can do" attitude, is a must
Functions, Duties, Task:
Independently apply scientific knowledge to develop highly robust and consistent fermentation manufacturing processes for the Elanco large molecule portfolio.
Organize and direct operations of the upstream processing team to satisfy multiple project requirements in a timely manner with high quality data.
Apply Quality by Design (QbD), Design of Experiment and data analysis for evaluation of multiple factor interactions to optimize quality and yields in vaccine manufacturing processes to ensure maximum customer satisfaction.
Serve as SME for Upstream Processing and collaborate with different functional groups PVST, ERL, TS/MS and M&Q at Elanco. Write tech transfer report and work with M&Q to implement process.
Support process development group with other project-related activity, such as Downstream Processing, Formulations and Analytics.
Plan, execute and coordinate daily and weekly work schedule. Design, review and make recommended changes to scientific protocols and procedures.
Maintain infrastructure of laboratory and an organized, clean and safe working environment.
Schedule and perform maintenance of instruments/equipment. Evaluate new laboratory equipment.
Use proper safety equipment and follow appropriate safety procedures. Takes responsibility for proper handling and disposal of biohazard materials and/or hazardous chemicals.
Able to organize, interpret and present results to peers, cross-functional teams and senior leadership
Write reports and may write external publications. Prepare SOPs/working procedures. Support preparation of registration documents.
Conceive, plan and execute technical projects to develop robust, repeatable and scalable processes. Perform data analysis and use results for the design of next experiment.
Able to perform troubleshooting activities.
Collaborate with other associates and scientists to facilitate knowledge exchange. Expand and strengthen the network of subject matter expertise internally and externally. Train and coach peers.
Work according to, and eventually ensure the compliance with, external and internal guidelines (e.g. SOP's, GxP, and HSE).
Internal Number: 52804
About Eli Lilly & Company
Company 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 39,000 employees worldwide 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.