Technical Leader - BioPharmaceutical Analytical Development

Zoetis   •  

Kalamazoo, MI

Industry: Biotech/Pharma

  •  

Not Specified years

Posted 340 days ago

This job is no longer available.

Zoetis is a global animal health company dedicated to supporting customers and their businesses . Building on 60 years of experience, we deliver quality medicines, biopharmaceuticals and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.

Zoetis discovers, develops and  manufacturesa diverse portfolio of animal health medicines, biopharmaceuticals and vaccines designed to meet the real-world needs of veterinarians and the livestock farmers and companion animal owners they support.  Zoetis has the first monoclonal antibody therapy for treating atopic dermatitis in dogs.  We are currently seeking to fill new positions to support our growing biopharmaceutical portfolio. 

Zoetis Veterinary Medicine Research and Development, Analytical Sciences in Kalamazoo, MI, and Lincoln, NE, is seeking an analytical scientist at the Senior Principal Scientist/Research Director level.

Responsibilities include, but are not limited to, the following:

  • Expand our expertise in analytical methodology and strategy related to biopharmaceutical development
  • Represent Zoetis at external meetings and with Regulatory agencies to define strategies for development and registration of biopharmaceuticals
  • Provide scientific and technical mentorship, including the possibility of direct supervision, dependent on past experience.
  • Represent Analytical Sciences on project teams, collaborating closely with scientists from Process Development, Biologicals Research, Clinical, Regulatory, Project Management, and Manufacturing to deliver robust methods and products.
  • Design and conduct laboratory experiments including analytical method development, validation and transfer.  Primary techniques are HPLC, peptide mapping, capillary electrophoresis, mass spectrometry, and new and emerging protein characterization methods. 
  • Develop and/or adopt new analytical technology, as appropriate, to advance programs with significant analytical technical and timeline challenges.
  • Collaborate with other scientists in a variety of technical disciplines including Process Development, Biological Research, Clinical, Regulatory, Project Management, Quality Control and Manufacturing.
  • Assist in the preparation and writing of regulatory filings.
  • Lead co-development teams partnering with manufacturing and taking responsibility to set strategy, communicate and drive work to develop robust products and methods and transfer processes and assays to Global Manufacturing and Supply.

Minimum Qualifications:

  • PhD or MS in  Analytical Chemistry, Biochemistry, or a related discipline with at least 10 years hands-on industry experience in protein characterization and methods development.
  • Experience developing, validating and transferring analytical methods
  • Pharmaceutical industry and biopharmaceutical development experience in a laboratory setting
  • Skills and past experience in experimental design, technical problem solving and continuous improvement
  • Good oral and written communication skills
  • Good leadership and partnership skills

Preferred Qualifications:

  • Extensive experience with immunological, biochemical and physicochemical analytical techniques, with application to new biopharmaceutical development, support of biological process development, development of in-process analytical technology.
  • Understanding of protein engineering and protein biophysical properties that relate to molecule stability and posttranslational modifications.
  • Extensive experience with biopharmaceutical development and licensure. 
  • First-hand knowledge of the regulatory requirements (FDA, EMA) that apply to the development of physical/chemical  methods for GMP control and release of biopharmaceuticals

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