Job Information
Zoetis Inc Biologics Formulation Scientist in Kalamazoo, Michigan
Role Description:
Zoetis Veterinary Medicine Research and Development (VMRD) is seeking an enthusiastic colleague for the position of Senior Scientist/Principal Scientist/Senior Principal Scientist for a challenging and fast-paced position in Biologics Product Development group in Kalamazoo, MI.
The incumbent is responsible for the design and execution of pre-formulation, formulation & process optimization studies, including scale-up, manufacture of clinical supplies, and transfer processes to pilot/manufacturing facilities. The scientist in this position is also responsible for working collaboratively with multi-disciplinary teams, author technical and regulatory documents, leading / supporting organizational initiatives, and assessing new capabilities / technologies. The selected individual is expected to have knowledge of protein biochemistry, lyophilization technology, protein stabilization approaches and familiarity with analytical techniques to characterize biopharmaceuticals.
The responsibilities for this role will include but not limited to: Design and conduct studies to characterize molecular and biophysical properties of peptides, proteins, monoclonal antibodies and other large molecules Design and development of parenteral biologic formulations (solutions, lyophilized products, and other dosage forms) Design and perform commercial process development studies for drug products by using expertise/knowledge of scale-down/scale-up principles Develop and optimize lyophilization-cycle Manufacture and supply formulations/drug product to non-pivotal and pivotal clinical studies Collaborate with and support pilot plant and manufacturing scientists for successful technology transfer for manufacture of pivotal/commercial drug product supplies. Author technical reports and contribute to regulatory documents Keep abreast of relevant new technologies & regulatory expectations/requirements Ensure work activities are aligned with relevant Quality, Regulatory and EHS requirements.
Basic Qualifications M.S (5+ years of relevant experience) or PhD (1-6 years of industrial experience) in Pharmaceutics or Pharmaceutical Sciences, Biochemistry, Chemical Engineering, Biomedical Engineering, or related field with research focus on formulation related issues with monoclonal antibodies, proteins, peptides, or vaccines.
Preferred Skills Experience/ advanced knowledge of parenteral formulation development for biologics Advanced understanding of protein chemistry, degradation pathways, and general approaches for stabilization Advanced knowledge of biophysical techniques and ability to apply them for characterization and problem-solving during formulation development Understanding of regulatory expectations and guidelines for biologics product development Knowledge of or experience in scale-up principles and late-stage formulation process development Ability to independently contribute from the bench Ability to coach, train and lead others in the design, execution and interpretation of experiments to drive the definition and optimization of formulations Good oral and written communication skills
Information about Zoetis:
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 manufactures a 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