Senior Scientist - Bioprocess Development

Role Description

The Senior Scientist / Principal 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 Subject Matter Expert (SME) 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 also providing strong technical and strategic leadership to project teams. 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 sciences. They will serve as a key technical resource within the line, may lead functional and cross-functional teams, and will have advanced knowledge of related bioprocessing unit operations such as cell line development, seed banking, and protein purification techniques. The position is based in Lincoln (Nebraska, USA) with frequent interactions with colleagues and external partners located around the globe.

Responsibilities:

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 engineering and configuration, medium formulation, and fed-batch strategies.

* Systematically identify and optimize the key parameters that affect bioreactor performance through the application of statistical models for experimental design and analysis.

* Perform and support antigen production, purification and/or concentration processes to support mono- and multivalent vaccine development.

* Partner in collaboration with colleagues in pilot and manufacturing scale operations to devise scale-up strategies for fermentation processes. Provide technical leadership using key knowledge of engineering first principles and computational flow dynamic (CFD) modelling in scale up programs based on risk assessment of critical parameters and their impact on product quality attributes.

* Perform set-up, operation and validation of equipment used to generate experimental data. Ensure the maintenance and performance of the equipment is kept in good operational status. Coordinate with internal and external sources to evaluate new technologies or troubleshoot issues with existing equipment.

* 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.

* Maintain electronic laboratory notebooks and records in accord with scientific protocol and applicable Standard Operating Procedures. Document experimental findings through periodic authorship of progress reports that will be included in dossiers for product registration and technology transfer.

Qualifications:

* Possess a relevant degree in science or engineering, such as Biochemistry, Molecular Biology, Cell Biology, Biotechnology, Chemical/Biochemical Engineering, or Biomedical Engineering.

o For Senior Scientist Level:

* BS candidates with a minimum of 15 years relevant experience

* MS candidates with a minimum of 10 years relevant experience

* PhD candidates with 0 - 2 years of relevant experience

o For Principal Scientist Level:

* MS candidates with a minimum of 15 years relevant experience

* PhD candidates with 3+ years of relevant experience

* Demonstrated track record as an independent researcher working in the field of bioprocess development.

* Advanced theoretical knowledge of the scientific disciplines that support bioprocess development and scale-up such as cell biology, industrial microbiology, or biochemical engineering.

* Demonstrated expertise in scaling and optimizing bacterial or eukaryotic expression systems is essential. Additional experience with viral propagation in cell culture environments is highly desirable. Advanced knowledge in the design and optimization of these systems to deliver cost-effective and robust manufacture of bacterial and viral antigens, subunit antigens or recombinant proteins in accord with the requirements of GMP.

* Able to troubleshoot problems and devise corrective solutions to solve the problem.

* Excellent laboratory technique and a strong technical knowledge of bioreactor design and operation including bioreactor engineering first principles and computational flow dynamics modelling.

* 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.

* 2-5 years of progressive leadership of functional and cross-functional teams is desirable.

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.