Senior Associate Scientist, Virology Bioprocess Development

Role Summary

Senior Associate Scientist, Virology Bioprocess Development based in Kalamazoo, MI. This role supports Zoetis vaccine strategies for veterinary medicine by developing virology production processes and transferring them to GMP manufacturing. You will design experiments for bioprocess development, work with mammalian cell and viral production methods, and maintain GLP documentation for regulatory submissions. The role involves BSL2 lab work, collaboration with bioprocess and analytical scientists, and producing antigen material for animal health clinical studies.

Responsibilities

• Serve as bioprocess project team representative and subject matter expert on cross-functional development project teams to meet timelines in support of product licensure.
• Provide finished oral and written communication reports to project teams, supervisor, and project governance bodies.
• Understand GLP/GMP guidance to provide high quality, regulatory compliant technical documentation in support of process transfers to manufacturing.
• Be responsible for later stage development and transfer of robust process to Pilot as well as Commercial Production.
• Serve as a technical liaison between Viral Bioprocess Group and other Zoetis partner groups such as Discovery research, Clinical, Pilot Plants, Manufacturing, Quality and Regulatory.

Qualifications

• Required: BS degree in Microbiology, Cell Biology, Biotechnology, chemical or biochemical engineering, or a related discipline with 3+ years of relevant academic and/or industry experience in Viral Process Development, OR a Master's degree and 2+ years of relevant academic and/or industry experience.
• Preferred: Experience in animal health vaccinology.
• Preferred: Experience with virus propagation and viral process development.
• Preferred: Knowledge of USDA and EU regulatory requirements for vaccine licensure.
• Preferred: Knowledge of GxPs, including process validation. Expertise in aseptic techniques and the handling and maintenance of mammalian cell lines, both at bench and in larger scale bioreactors.
• Preferred: Experience with cell culture and cell line propagation as well as experience working in a BSL-2 laboratory; experience handling infectious BSL-2 level virus.
• Preferred: Experience with DOEs and the use of biometrics in bioprocess study design and evaluation.
• Preferred: Experience with single use production equipment (e.g. wave reactor systems, S.U.B. reactor systems) and experience with media evaluation, development, and optimization.
• Preferred: Proven record of strong communication and teamwork skills, ability to multi-task, self-motivated and attention to detail.