The Scientist in Bacterial Bioprocess Development plays an essential role in the Zoetis vaccine and biopharmaceutical strategies for veterinary medicine. The successful applicant will work as a team member in the development of fermentation and bioreactor protocols in support of global product development and GMP (Good Manufacturing Practice) manufacture of biological veterinary products. The incumbent is expected to work hands-on at the bench while providing strong technical leadership to project teams within the discipline of biological manufacturing science. The Scientist is expected to work with a high degree of autonomy in the discipline and work on project teams in collaboration and partnership with colleagues in downstream process development, formulation development, and bioanalytical science. To be successful, they will have advanced knowledge of multiple platforms for cultivation of wild type micro-organisms and host prokaryotic systems for expression of recombinant proteins such as protein expression in prokaryotic or yeast hosts. They will serve as a technical resource within the line and will have a working knowledge of related bioprocessing unit operations such as cell line development, seed banking, and protein purification techniques including chromatography and membrane processing. The position is based in Lincoln (Nebraska, USA) with frequent interactions with colleagues and external partners located around the globe.
The major duties will include but are not limited to:
- Independently apply an advanced knowledge of biological manufacturing science in the design and execution of bioreactor experiments to identify and validate critical parameters that affect upstream and downstream bioprocess performance across multiple scales. The parameters to be investigated include reactor configuration, medium formulation, and fed-batch strategies.
- Systematically optimize the parameters that affect bioreactor performance through the application of statistical models for experimental design and analysis.
- Perform and support antigen purification and/or concentration processes to support mono- and multivalent vaccine development.
- Work in collaboration with colleagues in pilot and manufacturing scale operations to devise scale-up strategies for fermentation processes. Provide technical leadership in scale up programs based on computational flow dynamic modelling and risk assessment of critical parameters and their impact on product quality attributes.
- Contribute as an expert team member towards the supervision of bioprocess development work programs performed by contract development and manufacturing organizations.
- Serve as a technical resource to project teams by providing the essential expertise in biological manufacturing science required for successful project delivery. This includes a willingness to share experimental findings with team members, peers, and management.
- Independently drive innovation and continuous improvement by conducting laboratory experiments to evaluate new bioprocess technologies.
- Partner with scientists working in molecular biology and cell line development to conduct screening experiments with purpose to identify high-performing microbial strains.
- Document experimental findings through periodic authorship of progress reports that will be included in dossiers for product registration and technology transfer. Serve as a technical expert to project teams
- Maintain electronic laboratory notebooks and records in accord with scientific protocol and applicable Standard Operating Procedures.
- Minimum of BSc in Biochemistry, Biotechnology, Chemical or Biochemical engineering, or a related discipline. The successful Scientist BSc candidate would be expected to have >5 years of direct industry experience, a MSc candidate 3 - 5 years.
- Demonstrated track record as an independent researcher working in the field of bioprocess development.
- Strong theoretical knowledge of the scientific disciplines that support bioprocess development and scale-up such as cell biology, industrial microbiology, or biochemical engineering
- Comprehensive hands-on practical experience with one or more systems involving cultivation of wild type micro-organisms, yeasts, or prokaryotes for recombinant protein expression. Advanced knowledge in the design and optimization of these systems to deliver cost-effective and robust manufacture of subunit antigens or recombinant proteins in accord with the requirements of GMP.
- Experience with in-process analytical systems to monitor and control bioreactor experiments such as cell counting, metabolite profiling, and protein quantification.
- Excellent aseptic technique.
- Working knowledge of the principles for experimental execution using the methodologies of statistical Design of Experiments (DOE).
- Experience in scaling up bioreactor systems and technical transfer into manufacturing operations. Design and qualification of scale down models of bioreactor unit operations for the conduct of studies for bioprocess characterization.
- Demonstrated track record working as an independent scientific expert on multiple concurrent programs.
- A willingness to embrace and evaluate new technologies for the purpose to improve existing capabilities and workflows within the line.
- Knowledge of the regulatory (USDA, FDA, EMA) expectations for bioprocess design and technical transfer in alignment with principles of GMP.
- Excellent written and verbal communication skills.