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) and Design of Experiment concepts 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 PVST, ERL, TS/MS and M&Q. 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 processes. Perform data analysis and use results for the design of next experiment.
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, HSE, and AW).
PhD in Biotechnology, Biological sciences, Engineering or related fields.
At least two years of postdoctoral and/or industrial experience in biotechnology working on the development of bacterial fermentation processes from bench to pilot scale.
Thorough knowledge in bacterial fermentation and assessment of bacterial growth and product characterization by microbiological or suitable analytical techniques.
Experience in process development following QbD principles.
Knowledge in mammalian cell culture and assessment of growth and product characterization
Experience with downstream processing and/or formulations of vaccines and/or therapeutic proteins
Advancedknowledgeof English (oral and written).
Goodpresentationskills and scientific/technical writing skills.
Requires ability to lift 25 pounds and ability to stand for long periods of time.
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 1-5 scientists and 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.
Helping in establishing and strengthening QbD approaches, DOE designs and the implementation of computer and lab scale modeling for the team.
Setting 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.