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Scientist, Cell Culture and Virus Study
Requisition ID: 2287180130
The candidate for this position will lead and perform process development for the Cell Culture antibody process development within the API-Large Molecule group in Malvern, PA. The candidate’s primary responsibilities will include leading and participating in the design of cell culture experiments, executing the planned experiments, and optimizing the process steps to the target manufacturing process scale. This will include laboratory and occasional pilot-scale scale bioreactors. Additional responsibilities include:
- Lead the design and execution of development studies to identify and determine appropriate ranges of (critical) process parameters for cell culture, to optimize growth and product production
- Record and analyze experimental data, verify data integrity and accuracy, and report/summarize findings to the project team, and draft technical documents and perform technology transfer to collaboration partners
- Lead virus safety evaluation in antibody process development. Design experiments, transfer protocols to contract lab for execution, generate study summary reports, and draft sections for regulatory filling
- Presenting data at internal/external and department-wide meetings and summarize the data/results in appropriate reports where necessary
- Work in a team environment as well as contributing individually to meet project timeline and objectives
- PhD in Chemical Engineering or Biological Sciences or Biochemistry with relevant experience OR MS in Chemical Engineering or Biological Sciences or Biochemistry and with at least 9 years of relevant experience OR a BS in Chemical Engineering or Biological Sciences or Biochemistry and with at least 12 years of relevant experience is required
- Knowledge of and hands-on experience in the following areas mammalian cell culture, bioreactors, bioreactor process development, and bioreactor data analysis are required
- Experience with studies for scaling up to >10,000L is preferred
- Knowledge of and hands-on experience in antibody virus safety studies and evaluation is required
- A good understanding of cellular metabolism and analytical characterization of metabolites and protein is required
- Experience on cell culture data trending and statistic modeling for monoclonal antibodies in fed-batch cell culture processes is preferred
- Knowledge and hands-on experience with downstream processing and purification of antibodies, in particular chromatography is preferred
- Familiarity with and hands-on experience with analytical methods typically used in the manufacture and characterization of recombinant proteins is preferred
- Experience maintaining written records of work in the form of (electronic) notebooks, technical reports and protocols is required
- Occasional travel to manufacturing sites and weekend work may be required
Janssen Research & Development, LLC. (6084)