The Senior Scientist in downstream bioprocess development plays an essential role in the Zoetis biopharmaceutical and vaccine strategies for veterinary medicine. The successful applicant will work as a senior team member in the development of purification processes in support of global product development and GMP (Good Manufacturing Practice) manufacture of veterinary monoclonal antibodies derived from mammalian cell culture. 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 Senior Scientist is expected to work with a high degree of autonomy in the discipline and work on project teams in partnership with colleagues in cell culture development, bacteriology, virology, formulation development, and bioanalytical science. To be successful, they will have advanced knowledge of chromatographic and filtration processes for purifying proteins from both mammalian and prokaryotic expression systems. They will serve as a technical resource within the line and will have a working knowledge of related bioprocessing unit operations such as cell culture, fermentation, formulation and analytical characterization. The position is based in Kalamazoo (Michigan, USA) with frequent interactions with colleagues and external partners located around the globe.
- Independently develop and optimize robust, economical purification processes for recombinant proteins and monoclonal antibodies.
- Work with pilot and manufacturing colleagues to successfully transfer developed processes to a commercial environment.
- Perform process characterization studies on process steps (including DOE approaches) to identify and define proven acceptable parameter ranges and normal operating ranges.
- Understand and design viral inactivation/removal processes and work with vendors as necessary to preform viral clearance studies.
- Serve as a process expert for chromatography and filtration (cross-flow and dead-end) approaches as they pertain to both therapeutic proteins and vaccines.
- Perform antigen purification and/or viral concentration to support mono- and multivalent vaccine development.
- Author protocols, study reports, and technology transfer documents that will support technology transfer within the company or to contract manufacturers and well as to support regulatory filings for new product registrations.
- Represent DSP and Process Development on interdisciplinary project teams. Contribute at the technical level to the direction of the team and guide decision making in the context of DSP or process development as a whole.
- Coach and mentor junior Zoetis colleagues and provide direction to contingent workers and contractors providing support for DSP operations.
- Strive for continuous improvement by streamlining existing workflows to increase the volume of DSP work performed by the function while identifying opportunities to shorten the timelines for process development.
- Experience with protein modification and/or detoxification of toxins is highly desirable.
- Experience with isolation of inclusion bodies and protein folding is highly desirable.
- Maintain electronic laboratory notebooks and records in accord with scientific protocol and applicable Standard Operating Procedures.
- The position is located in the Bioprocess Development line within Laboratory Sciences. The Senior Scientist will interact with peers and colleagues working in disciplines that include cell culture, cell line development, bacteriology, virology, formulation development, and bioanalytical sciences.
- The position works in partnership with colleagues in Zoetis Global Therapeutic Research and Global Biological Research to develop new biopharmaceutical and biological candidates.
- Interaction with colleagues working in regulatory affairs for dossier preparation.
- Partnership with colleagues in Pilot operations and manufacturing to ensure efficient technical transfer of new candidates into GMP manufacturing operations.
- The Senior Scientist is expected to form collaborative working relationships with project team leaders and line representatives within team settings.
- The position also interacts with external parties including vendors, contractors, research collaborators, and contract manufacturers working in the DSP field.
EDUCATION AND EXPERIENCE
- BSc, MSc, or PhD in Biochemistry, Biotechnology, chemical or biochemical engineering, or a related discipline. The successful BSc candidate would be expected to have >7 years of industry experience in DSP, the MSc candidate 2-5 years, and the PhD candidate 0-5 years.
- Demonstrated track record as an independent researcher working in the field of protein chemistry.
TECHNICAL SKILLS REQUIREMENTS
- Strong theoretical knowledge in the scientific disciplines that support downstream processing such as protein chemistry, biotechnology, and biochemistry.
- Comprehensive hands-on practical experience in the tools used for downstream processing including multiple modalities of chromatography, cross-flow and dead-end filtration, cell disruption and removal, and supporting analytical techniques including UV-Vis spectrophotometry, gel electrophoresis, HPLC, and protein assays.
- Practical experience with automated chromatography software such as Unicorn (AKTA Explorer, Pure, Avant, Process, and/or Pilot).
- Demonstrated track record in developing purification processes for monoclonal antibodies and/or recombinant proteins.
- Excellent written and verbal communication skills.
- Demonstrated record of working in a team environment with highly developed interpersonal relationship skills.