What You Will Achieve
The incumbent will join the Early Bioprocess Development (EBPD) to develop state of the art mammalian cell culture processes for production of viruses or proteins of interest. The primary purpose of the position is to assure the proper design, planning, and execution of cell culture process development experiments. The position requires proven expertise in recombinant protein expression, virus production, process development and media optimization. The scope of responsibility includes the development and optimization of mammalian cell culture media and parameters to enhance growth, product yield and quality. Experience with bioreactor/WAVE systems is essential. The position also requires an appreciation of scale up and GMP manufacturing considerations. Careful documentation of work and effective presentation of data is required. How You Will Achieve It
- Design and execution of experiments to optimize and enhance protein/virus production using mammalian expression platforms
- Evaluate and incorporate media and feeds to improve cell culture processes for improved product yield and quality
- Develop assays to monitor and improve virus/protein titer and quality
- Design cell culture activities which focus on characterization, scale-up, and demonstration of process robustness
- Perform and analyze Design of Experiment (DOE) studies to fully characterize processes
- Participate in technology transfer initiatives via effective inter-departmental interfaces and author tech transfer documentation
- Collaborate with colleagues within Vaccine Research and Development organization including Bioprocess Purification, Analytical, and Formulation Development groups
- Propose solutions to scientific problems and offer insights based on experience to direct reports and other collaborating scientists
- Evaluate and implement new technologies to improve cell culture capabilities of process development group
- Streamline cell culture process to save time and cost of goods for continuous improvement
- Author and review cell culture procedures and reports, relevant parts in patent application and IND enabling documentation
- Maintain detailed records of the meetings and keep management informed as to progress or issues.
- Keep abreast of scientific/ technological development by participating in scientific meetings/ seminars and through regular scientific review.
- Where applicable, perform job responsibilities in compliance with GLP and all other regulatory agency requirements
- Satisfactorily complete all GLP and safety training in compliance with departmental requirements and follow appropriate safety practices in the workplace
- Perform timely notebook entries and review for completed experiments.
- Assure a strong alliance with the EBPD purification group to develop scale down purification models to help rapidly assess clones/strains and culture processes
Nice to Have
- BS or MS degree in Cell biology or Biochemical Engineering/Biomedical Engineering/Biochemistry/Chemistry/Biology or related discipline.
- BS with a minimum of 3 years ofrelated cell biology, biochemistry and cell culture experience.
- Hands on experience with development of culture process conditions, assay development and execution and high throughput technology is required
- Some experience with small-scale and large-scale mammalian cell culture bioreactor/WAVE process development equipment.
- Some experience with DOE and statistical analysis of data is required.
- Working knowledge of Cell Clarification/Harvest and Downstream purification
- Thorough understanding of protein chemistry.
- Solid understanding of principles of cell line development, virus propagation and titer determination.
- Experience to designing, organizing and executing multiple complex experiments simultaneously
- Experience with media development and optimization and familiarity with mammalian metabolic pathway
- Experience with virus culture, production and characterization using adherent cell or suspension cells
- Experience with AMBR/Perfusion/iCELLis/continuous processing
- Experience with molecular cloning, next generation sequencing, genome editing and bioinformatics
- Has a solid understanding of cGMP/ICH and regulatory requirements, in particular as they apply to the development of new processes.
- Some experience with protein/antibody purification/characterization
The ability to make aseptic transfers and perform the relevant laboratory functions.
Mental requirements are a detailed understanding of the scientific subject matter, an ability to make scientific judgments and an ability to perform complex data analysis. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May work irregular hours (weekends and outside of 9-5 format) as experiments warrant OTHER JOB DETAILS
Eligible for Relocation Support
Eligible for Employee Referral Bonus
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Research and Development